Home GUDID 00821329000720 OptiSeal™
Primary DI 00821329000720
Brand OptiSeal™
Company Greatbatch Ltd
Model 1000093-002
Catalog number 1000093-002
Device description Valved Peelable PTFE Introducer
Published 2019-08-15
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 20821329000724 Package GS1 5 In Commercial Distribution 00821329000720 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 20821329000724 20821329000724 00821329000720 00821329000720 821329000720 0821329000720
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 Catheter Gauge 0 Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0
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# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00821329000317 PTFE Peelable Introducer Kit 1000558-001 7087 2018-09-24 00821329000324 PTFE Peelable Introducer Kit 667088-351 7088 2017-10-26 00821329000331 PTFE Peelable Introducer Kit 667087-351 7087 2017-10-26 00821329000348 PTFE Peelable Introducer Kit 667089-351 7089 2017-10-26 00821329000355 PTFE Peelable Introducer Kit 667091-351 7091 2017-10-26 00821329000362 PTFE Peelable Introducer Kit 667093-351 7093 2017-10-26 00821329000416 Greatbatch Steerable Sheath 10876-001 10876-001 2017-10-19 00821329000423 Greatbatch Steerable Sheath 10876-002 10876-002 2017-10-19 00821329000430 RadialSeal™ Introducer Kit, SS Wire SPC-000653-007 2018-09-24 00821329000447 RadialSeal™ Introducer Kit, SS Wire SPC-000653-009 2018-09-24 00821329000454 RadialSeal™ Introducer Kit, SS Wire SPC-000653-008 2018-09-24 00821329000461 RadialSeal™ Introducer Kit, Poly Wire SPC-000654-007 2018-09-24 00821329000478 RadialSeal™ Introducer Kit, Poly Wire SPC-000654-008 2018-09-24 00821329000485 RadialSeal™ Introducer Kit, Poly Wire SPC-000654-009 2018-09-24 00821329000508 PTFE Peelable Introducer Kit 667131-351 7131 2017-10-26 00821329000515 PTFE Peelable Introducer Kit 667133-351 7133 2017-10-26 00821329000522 PTFE Peelable Introducer Kit 667090-351 7090 2017-10-26 00821329000539 PTFE Peelable Introducer Kit 667096-351 7096 2017-10-26 00821329000546 PTFE Peelable Introducer Kit 667097-351 7097 2017-10-26 00821329000553 PTFE Peelable Introducer Kit 667099-351 7099 2017-10-26
Other Devices Sharing Product Codes#