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Date of Notification
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Title
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FSN
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29 Oct 2015
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Access CEA Reagent Kit, Beckman Coulter Inc (HSA 600:41/01-052/15/09_38)
Local Contact: Beckman Coulter Singapore Pte Ltd
Contact no./Email: 63047126
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HSA 6004101-052-15-09_38 FSN94 KB
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27 Oct 2015
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Revolution CT Scanners, GE Medical Systems LLC (HSA 600:41/01-010/15/21_56)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 62773552
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HSA 6004101-010-15-21_56 FSN72 KB
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27 Oct 2015
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Synchron Systems Enzymatic Creatinine (CR-E) and Uric Acid (URIC) Reagents, Beckman Coulter Inc (HSA 600:41/01-052/15/08_34)
Local Contact: Beckman Coulter Singapore Pte Ltd
Contact no./Email: 63407126
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HSA 6004101-052-15-08_34 FSN98 KB
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26 Oct 2015
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TheraSphere Y-90 Glass Microspheres Injection, Biocompatibles UK Ltd (HSA 600:41/01-263/15/03_48)
Local Contact: Emergo Singapore Consulting Pte Ltd
Contact no./ Email: 68325625
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HSA 6004101-263-15-03_48 FSN1234 KB
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23 Oct 2015
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Stryker 2-Stage and 3-Stage I.V. Poles, Stryker Medical (HSA 600:41/01-014/15/13_54)
Local Contact: Stryker Singapore Pte Ltd
Contact no./ Email: 65009501
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HSA 6004101-014-15-13_54 FSN55 KB
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23 Oct 2015
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VariSource™ iX Control Software, Varian Medical Systems (HSA 600:41/01-058/15/03_46)
Local Contact: Varian Medical Systems Pacific Inc
Contact no./ Email: 68870028, 66900714
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HSA 6004101-058-15-03_46 FSN257 KB
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23 Oct 2015
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Amphirion® Deep Percutaneous Transluminal Angioplasty (PTA) Balloon Dilation Catheter, Invatec S.p.A (HSA 600:41/01-009/15/16_55)
Local Contact: Covidien Private Limited
Contact no./ Email: 64365000
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HSA 6004101-009-15-16_55 FSN114 KB
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22 Oct 2015
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GENESIS II Constrained Articular Insert, Smith & Nephew Inc, Smith & Nephew Inc (HSA 600:41/01-073/15/09_53)
Local Contact: Smith & Nephew Pte Ltd
Contact no./ Email: singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-15-09_53 FSN72 KB
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19 Oct 2015
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Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer, GE Healthcare (HSA 600:41/01-010/15/19_41)
Local Contact: GE Healthcare Pte Ltd
Contact no./ Email: 62777668
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HSA 6004101-010-15-19_41 FSN60 KB
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19 Oct 2015
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Centricity PACS-IW, GE Healthcare (HSA 600:41/01-010/15/20_51)
Local Contact: GE Healthcare Pte Ltd
Contact no./ Email: 62777668
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HSA 6004101-010-15-20_51 FSN62 KB
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19 Oct 2015
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chronOS Inject Bone Void Filler, Synthes GmbH (HSA 600:41/01-002/15/46_49)
Local contact: Johnson & Johnson Pte Ltd
Contact no./ Email: 68276135
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HSA 6004101-002-15-46_49 FSN123 KB
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19 Oct 2015
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Welch Allyn KleenSpec® Corded Illumination System, Welch Allyn Inc. (HSA 600:41/01-006/15/01_52)
Local contact: HOYA Medical Singapore Pte Ltd
Contact no./ Email: 64198153
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HSA 6004101-006-15-01_52 FSN142 KB
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19 Oct 2015
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HOYA Preloaded iSert Intraocular lenses (IOLs), HOYA Corporation Inc (HSA 600:41/01-206/15/01_36)
Local contact: Welch Allyn Singapore Pte Ltd
Contact no./ Email: 66810000
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HSA 6004101-206-15-01_36 FSN159 KB
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16 Oct 2015
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Sydney IVF PVP (K-SIPV), William A Cook Australia Pty Ltd (HSA 600:41/01-013/15/05_37)
Local contact: Cook South East Asia Pte Ltd
Contact no./ Email: 62877888
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HSA 6004101-013-15-05_37 FSN134 KB
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16 Oct 2015
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Philips Pinnacle 3 Radiation Therapy Planning System, Philips Medical Systems (Cleveland) Inc (HSA 600:41/01-026/15/34_35)
Local contact: Philips Electronics (S) Pte Ltd
Contact no./ Email: 18007445477
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HSA 6004101-026-15-34_35 FSN142 KB
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16 Oct 2015
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Unitek Victory Mini Tube Lower Left Buccal Tube, 3M Unitek Corporation (HSA 600:41/01-031/15/02_33)
Local contact: 3M Technologies (S) Pte Ltd
Contact no./ Email: 64508846
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HSA 6004101-031-15-02_33 FSN44 KB
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15 Oct 2015
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iPlan RT Image (below v4.1.2) / iPlan RT, BrainLab AG (HSA 600:41/01-047/15/08_19)
Local contact: BrainLab Limited (Singapore Branch)
Contact no./ Email: sg.sales@brainlab.com
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HSA 6004101-047-15-08_19 FSN700 KB
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14 Oct 2015
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ORTHO BioVue® System Cassettes, Ortho-Clinical Diagnostics, Inc (HSA 600:41/01-002/15/45_22)
Local contact: Johnson & Johnson Pte Ltd
Contact no./ Email: 68276135
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HSA 6004101-002-15-45_22 FSN167 KB
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14 Oct 2015
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ARIA® for Radiation Oncology, ARIA® Oncology Information System for Radiation Oncology, Varian Medical Systems, Inc. (HSA 600:41/01-058/15/02_48)
Local contact: Varian Medical Systems Pacific, Inc.
Contact no./ Email: 68870028
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HSA 6004101-058-15-02_48 FSN157 KB
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14 Oct 2015
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Allura Xper FD, Philips Medical Systems Nederland B.V. (HSA 600:41/01-026/15/32_56)
Local contact: Philips Electronics (S) Pte Ltd
Contact no./ Email: 1800 744 5477
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HSA 6004101-026-15-32_56 FSN400 KB
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14 Oct 2015
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Silimed Implants, Silimed Industria De Implantes Ltda (HSA 600:41/01-284/15/01_12)
Local contact: Alpha-Health (Asia) Pte Ltd
Contact no./ Email: 63396678
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HSA 6004101-284-15-01_12 FSN118 KB
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14 Oct 2015
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Giraffe Shuttle, Ohmeda Medical (HSA 600:41/01-010/15/17_17)
Local contact: GE Healthcare Pte Ltd
Contact no./ Email: svc@ge.com
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HSA 6004101-010-15-17_17 FSN182 KB
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14 Oct 2015
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Philips HeartStart MRx Defibrillator/Monitor, Philips Medical Systems (HSA 600:41/01-026/15/33_29)
Local contact: Philips Medical Systems
Contact no./ Email: 1800 744 5477
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HSA 6004101-026-15-33_29 FSN246 KB
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14 Oct 2015
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MR Surgical Suite II MR system, GE Medical Systems LLC (HSA 600:41/01-010/15/18_25)
Local contact: GE Healthcare Pte Ltd
Contact no./ Email: postmarket@ge.com
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HSA 6004101-010-15-18_25 FSN53 KB
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13 Oct 2015
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Biosense Webster CARTOSOUND Module in conjunction with SOUNDSTAR eco 8F and eco 10F catheters, Biosense Webster Inc (HSA 600:41/01-002/15/44_46)
Local contact: Johnson & Johnson Pte Ltd
Contact no./ Email: 68276135
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HSA 6004101-002-15-44_46 FSN33 KB
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12 Oct 2015
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ADVIA Chemistry XPT system, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/15/54_61)
Local contact: Siemens Healthcare Pte Ltd
Contact no./ Email: ui-handling.sg@siemens.com
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HSA 6004101-022-15-54_61 FSN86 KB
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12 Oct 2015
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Urinary Metanephrines by HPLC, Bio-Rad Laboratories GmbH (HSA 600:41/01-027/15/03_23)
Local contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./ Email: 6490 4262
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HSA 6004101-027-15-03_23 FSN155 KB |
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12 Oct 2015
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Amicus Cell Separator, Fresenius Kabi AG (HSA 600:41/01-020/15/02_45)
Local contact: Fresenius Kabi (Singapore) Pte Ltd
Contact no./ Email: 68372552
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HSA 6004101-020-15-02_45 FSN74 KB
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12 Oct 2015
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Duracon Tibial Wedge Augments, Howmedica Osteonics Corp (HSA 600:41/01-014/15/12_54)
Local contact: Stryker Singapore Pte Ltd
Contact no./ Email: 65009507
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HSA 6004101-014-15-12_54 FSN23 KB
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07 Oct 2015
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STERRAD® NX® Sterilization System, Advanced Sterilization Products (HSA 600:41/01-002/15/42_52)
Local contact: Johnson & Johnson Pte Ltd
Contact no./ Email: 68276135
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HSA 6004101-002-15-42_52 FSN93 KB
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07 Oct 2015
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ORTHO VISION™ Analyzer for ORTHO BioVue® Cassette, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-002/15/43_59)
Local contact: Johnson & Johnson Pte Ltd
Contact no./ Email: 68276135
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HSA 6004101-002-15-43_59 FSN107 KB
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07 Oct 2015
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MiniMed® 640G Insulin pump, Medtronic Minimed (HSA 600:41/01-009/15/15_44)
Local contact: Medtronic International Limited
Contact no./ Email: 64365000
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HSA 6004101-009-15-15_44 FSN209 KB
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07 Oct 2015
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Triathlon MIS Modular Distal Capture, Howmedica Osteonics Corp (HSA 600:41/01-014/15/11_53)
Local contact: Stryker Singapore Pte Ltd
Contact no./ Email: 65009507
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HSA 6004101-014-15-11_53 FSN50 KB
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06 Oct 2015
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Exeter Small Tapered Pin Reamer and Exeter Large Tapered Pin Reamer, Howmedica Osteonics Corp (HSA 600:41/01-014/15/10_51)
Local contact: Stryker Singapore Pte Ltd
Contact no./ Email: 65009507
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HSA 6004101-014-15-10_51 FSN38 KB
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05 Oct 2015
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HARMONIC ACE+7 Shears with Advanced Haemostasis, Ethicon Endo-Surgery LLC (HSA 600:41/01-002/15/41_50)
Local contact: Johnson & Johnson Pte Ltd
Contact no./ Email: 68276135
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HSA 6004101-002-15-41_50 FSN313 KB
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02 Oct 2015
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Medtronic Navigated Solera Screwdrivers, Medtronic Navigation Inc (HSA 600:41/01-009/15/14_36)
Local contact: Medtronic International Limited
Contact no./ Email: 64365000
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HSA 6004101-009-15-14_36 FSN1615 KB
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02 Oct 2015
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Brilliance 16-Slice (Air)/ 64 CT/ CT Big Bore, Ingenuity Core/ Ingenuity Core^128/ Flex, Philips Medical Systems Inc (HSA 600:41/01-026/15/31_37)
Local contact: Philips Electronics (S) Pte Ltd
Contact no./ Email: 18007445477
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HSA 6004101-026-15-31_37 FSN316 KB
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02 Oct 2015
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Narrow Right Angle Large Driver Tip and Narrow Right Angle Square Driver Tip, Biomet 3i (HSA 600:41/01-181/15/01_35)
Local contact: Asia Implant Support & Services
Contact no./ Email: admin@implant.com.sg
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HSA 6004101-181-15-01_35 FSN55 KB
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01 Oct 2015
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Sciatic Nerve Retractors, Synthes GmbH (HSA 600:41/01-002/15/39_29)
Local contact: Johnson & Johnson Pte Ltd
Contact no./ Email: 68276135
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HSA 6004101-002-15-39_29 FSN67 KB
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01 Oct 2015
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VITROS® Chemistry Products Calibrator Kit 9, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-002/15/40_57)
Local contact: Johnson & Johnson Pte Ltd
Contact no./ Email: 68276135
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HSA 6004101-002-15-40_57 FSN122 KB
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01 Oct 2015
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ConforMIS iTotal Knee Replacement Systems, ConforMIS Inc (HSA 600:41/01-263/15/02_33)
Local contact: Emergo Consulting Pte Ltd
Contact no./ Email: SEAvigilance@emergogroup.com
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HSA 6004101-263-15-02_33 FSN141 KB
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