Home GUDID M20689960 VSI Radial™ introducer sheath
Primary DI M20689960
Brand VSI Radial™ introducer sheath
Company Vascular Solutions, Inc.
Model 8996
Device description The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of guidewires, catheters and other accessory medical devices through the skin into a vein or artery and minimize blood loss associated with such introduction.
Published 2016-09-05
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name DYB Introducer, Catheter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DYB Introducer, Catheter Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M20689961 Package HIBCC 5 Not in Commercial Distribution M20689960 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Vascular catheter introduction set, nonimplantable A collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Catheter Gauge 4 French Device Size Text, specify 0 Needle Gauge 21 Gauge
Regulatory Flags# DUNS number 008999906 Device count 1 Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published M20679600 VSI StraitSet™ micro-introducer kit 7960 2018-08-09 M20679610 VSI StraitSet™ micro-introducer kit 7961 2018-08-09 M20679620 VSI StraitSet™ micro-introducer kit 7960 2018-08-09 M20679640 VSI StraitSet™ micro-introducer kit 7960 2018-08-09 M20679650 VSI StraitSet™ micro-introducer kit 7961 2018-08-09 M20679710 VSI StraitSet™ micro-introducer kit 7961 2018-08-09 M206780500 SmartNeedle® vascular access system 78050 2016-09-06 M206780600 SmartNeedle® vascular access system 78060 2016-09-06 M206780300 SmartNeedle® vascular access system 78030 2016-09-05 M206780400 SmartNeedle® vascular access system 78040 2016-09-06 M206720000 SmartNeedle® monitor 72000 2016-09-23 M20631010 Thrombix® Hemostasis Patch topical hemostat 3101 2016-09-15 M20630100 D-Stat® 2 Dry topical hemostat 3010 2016-09-15 M20681500 Teirstein Edge™ device organizer 8150 2016-09-05 M20681510 Angio Assist™ docking station 8151 2016-09-05 M20673710 Axis™ guidewire 7371 2016-09-05 M20673720 Axis™ guidewire 7372 2016-09-05 M20674720 VSI Tru-Torque™ guidewire 7472 2016-09-05 M20674730 VSI Tru-Torque™ guidewire 7473 2016-09-05 M20674790 Amplatz SST™ guidewire 7479 2016-09-05
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850084947001 Genie MAX CULTIV8 1, LLC DYB 2026-05-29 G440VIZ1750 Multiflex Vizaramed, Inc. DYB 2026-04-09 08498840011300 VYGON Vygon Corporation DYB 2019-04-08 08498840011317 VYGON Vygon Corporation DYB 2019-04-08 08498840011751 VYGON Vygon Corporation DYB 2019-04-08 08498840011768 VYGON Vygon Corporation DYB 2019-04-08 08498840011775 VYGON Vygon Corporation DYB 2019-04-08 08498840011782 VYGON Vygon Corporation DYB 2019-04-08 08498840011799 VYGON Vygon Corporation DYB 2019-04-08 08498840011805 VYGON Vygon Corporation DYB 2019-04-08 08498840011812 VYGON Vygon Corporation DYB 2019-04-08 08498840012215 VYGON Vygon Corporation DYB 2019-04-08 H965481030 ENVI NAVILYST MEDICAL, INC. DYB 2019-01-03 07613327459210 AXS VECTA 71 Stryker Corporation DYB 2018-10-26 07613327459227 AXS VECTA 71 Stryker Corporation DYB 2018-10-26 07613327459234 AXS VECTA 71 Stryker Corporation DYB 2018-10-26 00813502010664 Introducer Kit for Impella® Oscor Inc. DYB 2017-11-30 00813502010237 Introducer Kit for Impella® Oscor Inc. DYB 2017-11-18 00813502010244 Introducer Kit for Impella® Oscor Inc. DYB 2017-11-18 00813502010558 Introducer Kit for Impella® Oscor Inc. DYB 2017-11-18 H965481080 Navylist NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355010 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355020 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355030 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355060 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355080 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355090 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355110 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355120 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355130 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07
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