Home GUDID H965914004001 NAMIC
Primary DI H965914004001
Brand NAMIC
Company NAVILYST MEDICAL, INC.
Model 91400400
Device description Guidewire Introducer
Published 2016-09-21
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 LIT Catheter, angioplasty, peripheral, transluminal
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status H965914004001 Package HIBCC 10 In Commercial Distribution H965914004000 Primary HIBCC 0
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.
Regulatory Flags# DUNS number 809699023 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true 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 08033477048772 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048802 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048833 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048864 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048888 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048925 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048956 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048987 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049014 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049045 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049069 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049076 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049106 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049137 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049168 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049199 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049212 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049229 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049250 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049281 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049311 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049373 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049434 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049397 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049090 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048727 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048734 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048765 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048796 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048819 REEF HP MEDTRONIC, INC. LIT 2016-06-19
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