Home GUDID 00821925033306 GYRUS ACMI
Primary DI 00821925033306
Brand GYRUS ACMI
Company Gyrus ACMI, LLC
Model 130700
Device description EAR SPECULUM ADULT, 5 MM DISPOSABLE
Published 2018-09-04
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name EPY SPECULUM, ENT
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EPY Speculum, Ent General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00821925014459 Package GS1 6 In Commercial Distribution 00821925033306 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 00821925014459 00821925014459 821925014459 0821925014459 00821925033306 00821925033306 821925033306 0821925033306
GMDN Terms# Term, Definition table Term Definition Ear speculum, single-use A semi-rigid or rigid, plastic or metal tube that is cone-shaped (i.e., it tapers down from a standard instrument fitting size to a small opening) and is either hand-held and manually inserted, or fitted onto a compatible otoscope, and then inserted into the ear canal to create a channel for examination, suction, irrigation, or the insertion of another surgical device during an ear/nose/throat (ENT) procedure. It may be referred to as an ear cannula. This is a single-use device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 007198742 Device count 1 Premarket exempt true Lot or batch true Expiration date on label true Sterilization required before use true 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#