Home GUDID 10821329000352 PTFE Peelable Introducer Kit
Primary DI 10821329000352
Brand PTFE Peelable Introducer Kit
Company Greatbatch Ltd
Model 667091-351
Catalog number 7091
Published 2017-10-26
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 Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10821329000352 Package GS1 1 In Commercial Distribution 00821329000355 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 10821329000352 10821329000352 00821329000355 00821329000355 821329000355 0821329000355
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 8 French Device Size Text, specify 0 Length 14 Centimeter Length 60 Centimeter Length 70 Millimeter Lumen/Inner Diameter 0.9 Millimeter Lumen/Inner Diameter 2.7 Millimeter Needle Gauge 18 Gauge Outer Diameter 0.89 Millimeter Outer Diameter 2.9 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#