Home GUDID 00813502010558 Introducer Kit for Impella®
Primary DI 00813502010558
Brand Introducer Kit for Impella®
Company Oscor Inc.
Model 0052-3021
Catalog number 0052-3021
Device description Hemostatic Peel Away Introducer System with Infusion Sideport, 23F
Published 2017-11-18
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
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 00813502010558 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00813502010558 00813502010558 813502010558 0813502010558
GMDN Terms# Term, Definition table Term Definition Vascular catheter introduction set, nonimplantable A collection of 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 Length 0
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 0 0
Regulatory Flags# DUNS number 101835833 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# 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 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 H965355160 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07
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