Home GUDID 10821329601368 OptiSeal™
Primary DI 10821329601368
Brand OptiSeal™
Company Greatbatch Ltd
Model 1003975-002
Device description Valved Peelable PTFE Introducer
Published 2018-12-10
Public version status Update
Distribution status 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 10821329601368 Package GS1 5 In Commercial Distribution 00821329601361 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 10821329601368 10821329601368 00821329601361 00821329601361 821329601361 0821329601361
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 Length 13 Centimeter Length 60 Centimeter Lumen/Inner Diameter 2.5 Millimeter Needle Gauge 18 Gauge Outer Diameter 0.89 Millimeter Total Volume 12 Milliliter
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 0 Degrees Celsius 40 Degrees Celsius
Regulatory Flags# DUNS number 968623467 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true 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 10884450114008 Prelude IDeal™ Merit Medical Systems, Inc. DYB 2026-06-09 10884450119799 Prelude EASE™ Merit Medical Systems, Inc. DYB 2026-06-09 10884450114855 Prelude IDeal™ Merit Medical Systems, Inc. DYB 2026-06-08 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