Home GUDID 00821925042391 Gyrus ACMI
Primary DI 00821925042391
Brand Gyrus ACMI
Company Gyrus ACMI, LLC
Model 890912
Device description EPISTAXIS BALOON CATHETER KIT. CONTAINS: ONE CATHETER, ONE 10 CC SYRINGE AND TWO 4 x 4". GAUZE PADS
Published 2024-07-25
Public version status Update
Distribution status Not 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 EMX Balloon, Epistaxis
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EMX Balloon, Epistaxis Ear, Nose, Throat 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00821925022379 Package GS1 1 Not in Commercial Distribution 00821925042391 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 00821925022379 00821925022379 821925022379 0821925022379 00821925042391 00821925042391 821925042391 0821925042391
GMDN Terms# Term, Definition table Term Definition Intranasal splint, non-bioabsorbable, animal-derived A non-bioabsorbable device intended to be temporarily placed via a nostril into the nasal cavity after surgery or trauma to help minimize bleeding by tamponade effect, prevent adhesions between the mucosal surfaces, and/or provide support to the surrounding tissues during the healing period. It is made from animal-derived materials (e.g., chitosan) and is removed at the discretion of the physician. This is a single-use device.
Regulatory Flags# DUNS number 007198742 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit true 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 false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00821925019157 VOCOM 143000 2015-10-24 00821925019164 GYRUS ACMI, INC 143001 2015-10-24 00821925019171 GYRUS ACMI, INC 143002 2015-10-24 00821925019225 GYRUS ACMI, INC 143006 2015-10-24 00821925019232 GYRUS ACMI, INC 143007 2015-10-24 00821925019249 GYRUS ACMI, INC 143008 2015-10-24 00821925019300 GYRUS ACMI, INC 143003 2015-10-24 00821925019317 GYRUS ACMI, INC 143004 2015-10-24 00821925019324 GYRUS ACMI, INC 143005 2015-10-24 00821925012738 EVONOS GMBH & Co. Kg 130015 2018-09-04 00821925012783 EVONOS 130020 2018-09-06 00821925012790 EVONOS 130021-ENT 2018-09-06 00821925012806 EVONOS 130022 2018-09-06 00821925012813 EVONOS 130023 2018-09-06 00821925012820 EVONOS 130024 2018-09-06 00821925012837 Gyrus ACMI 130025-ENT 2018-09-06 00821925012929 EVONOS 130038 2018-09-06 00821925013001 EVONOS 130201 2018-09-10 00821925013018 EVONOS 130202 2018-09-10 00821925013025 EVONOS 130203 2018-09-10
Other Devices Sharing Product Codes#