Home GUDID M991IK812211 Standard Introducer
Primary DI M991IK812211
Brand Standard Introducer
Company NORFOLK MEDICAL
Model Straight Wing Tearaway
Catalog number IK81221
Device description 11F Standard Introducer Kit
Published 2015-09-01
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 M991IK812212 Package HIBCC 2 In Commercial Distribution M991IK812211 Primary HIBCC 0
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/or a vascular catheter introduction needle (e.g., arterial needle), and typically an additional access device(s) [e.g., guidewire, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually for arterial access; some sets include in addition noninvasive supportive devices (e.g., drapes, dressings). This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Length 0
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 013861471 Device count 1 DM exempt true 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 true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published M991IK312211 Standard Introducer Straight Wing Tearaway IK31221 2015-09-01 M991IK512211 Standard Introducer Straight Wing Tearaway IK51221 2015-09-01 M991IK522211 Valved Introducer Flowguard IK52221 2015-09-01 M991IK712211 Standard Introducer Straight Wing Tearaway IK71221 2015-09-01 M991IK722211 Valved Introducer Flowguard IK72221 2015-09-01 M991CVS611101 Clear-View Subcutaneous Infusion Set "Clear-View ""Sub-Q""" CVS61110 2021-11-18 M991CVS612101 Clear-View Subcutaneous Infusion Set "Clear-View ""Sub-Q""" CVS61210 2021-11-18 M991CVS615101 Clear-View Subcutaneous Infusion Set "Clear-View ""Sub-Q""" CVS61510 2021-11-18 M991CVS622101 Clear-View Subcutaneous Infusion Set "Clear-View ""Sub-Q""" CVS62210 2021-11-18 M991CVS611102 Clear-View Subcutaneous Infusion Set Clear-View "Sub-Q" CVS61110 2021-11-18 M991CVS612102 Clear-View Subcutaneous Infusion Set Clear-View "Sub-Q" CVS61210 2021-11-18 M991CVS615102 Clear-View Subcutaneous Infusion Set Clear-View "Sub-Q" CVS61510 2021-11-18 M991CVS622301 Clear-View Subcutaneous Infusion Set "Clear-View ""Sub-Q""" CVS62230 2021-11-04 M991SCIG331361 Clear-View Multi-site Subcutaneous Infusion Set ClearView™MS SCIG33136 2020-10-19 M991TH011001 Tidal High-Flow Non-coring Needle Tidal-HF TH01100 2015-10-06 M991TH012001 Tidal High-Flow Non-coring Needle Tidal-HF TH01200 2015-10-06 M991TH013001 Tidal High-Flow Non-coring Needle Tidal-HF TH01300 2015-10-06 M991TH021001 Tidal High-Flow Non-coring Needle Tidal-HF TH02100 2015-10-06 M991TH022001 Tidal High-Flow Non-coring Needle Tidal-HF TH02200 2015-10-06 M991TH023001 Tidal High-Flow Non-coring Needle Tidal-HF TH02300 2015-10-06
Other Devices Sharing Product Codes# 
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