Home GUDID 10821329600255 OptiSeal™
Primary DI 10821329600255
Brand OptiSeal™
Company Greatbatch Ltd
Model 1000093-010
Device description Valved Peelable PTFE Introducer
Published 2018-09-24
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 10821329600255 Package GS1 5 In Commercial Distribution 00821329600258 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 10821329600255 10821329600255 00821329600258 00821329600258 821329600258 0821329600258
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 25 Centimeter Length 60 Centimeter Lumen/Inner Diameter 2.8 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 00849884007541 VYGON Vygon Corporation DYB 2026-05-22 00849884007558 VYGON Vygon Corporation DYB 2026-05-22 20886333227864 V-Stick Vascular Access Set ARGON MEDICAL DEVICES, INC. DYB 2026-03-20 20886333227871 V-Stick Vascular Access Set ARGON MEDICAL DEVICES, INC. DYB 2026-03-20 20886333227888 V-Stick Vascular Access Set ARGON MEDICAL DEVICES, INC. DYB 2026-03-20 20886333227895 V-Stick Vascular Access Set ARGON MEDICAL DEVICES, INC. DYB 2026-03-20 20886333227901 V-Stick Vascular Access Set ARGON MEDICAL DEVICES, INC. DYB 2026-03-20 20886333227918 V- Stick Vascular Access Set ARGON MEDICAL DEVICES, INC. DYB 2026-03-20 20886333227925 V-Stick Vascular Access Set ARGON MEDICAL DEVICES, INC. DYB 2026-03-20 20886333227932 V-Stick Vascular Access Set ARGON MEDICAL DEVICES, INC. DYB 2026-03-20 00813502010411 Impella RP Flex Introducer Kit Abiomed, Inc. DYB 2026-03-11 00813502011685 Abiomed Impella CP 14Fr Introducer Kit Abiomed, Inc. DYB 2026-03-11 00813502011692 Abiomed Impella CP 14Fr Introducer Kit Abiomed, Inc. DYB 2026-03-11 20801902225508 ARROW TELEFLEX INCORPORATED DYB 2026-03-11 20801902225546 ARROW TELEFLEX INCORPORATED DYB 2026-03-11 00840479401263 enableCV Introducer Sheath ENABLECV INC. DYB 2026-02-26 20884450113992 Prelude IDeal™ Merit Medical Systems, Inc. DYB 2026-02-25 20884450115804 Prelude IDeal™ Merit Medical Systems, Inc. DYB 2026-02-25 00884450489642 Prelude SNAP™ Merit Medical Systems, Inc. DYB 2026-02-21 30884908188456 MICRO-STICK SET Medical Components, Inc. DYB 2026-02-19 30884908188463 MICRO-STICK SET Medical Components, Inc. DYB 2026-02-19 50884908188474 MICRO-STICK SET Medical Components, Inc. DYB 2026-02-19 50884908188481 MICRO-STICK SET Medical Components, Inc. DYB 2026-02-19 20801902225362 ARROW TELEFLEX INCORPORATED DYB 2026-02-17 20884450119475 Prelude EASE™ Merit Medical Systems, Inc. DYB 2026-02-14 50382903829120 Insyte Autoguard BECTON, DICKINSON AND COMPANY DYB 2026-02-13 30382903829249 Insyte Autoguard BECTON, DICKINSON AND COMPANY DYB 2026-02-13 50382903829472 Insyte Autoguard BECTON, DICKINSON AND COMPANY DYB 2026-02-13 50382903829540 Insyte Autoguard BECTON, DICKINSON AND COMPANY DYB 2026-02-13 20801902225133 ARROW TELEFLEX INCORPORATED DYB 2026-02-13