Home GUDID 00821925014756 EVONOS GMBH & Co. Kg
Primary DI 00821925014756
Brand EVONOS GMBH & Co. Kg
Company Gyrus ACMI, LLC
Model 130630
Device description EAR SURGERY SPECULUM ROUND 3.0MM BEVELED
Published 2018-09-10
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name EPY Speculum, Ent KCJ APPLICATOR, ENT
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EPY Speculum, Ent General, Plastic Surgery 1 KCJ Applicator, Ent Ear, Nose, Throat 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00821925014756 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 00821925014756 00821925014756 821925014756 0821925014756
GMDN Terms# Term, Definition table Term Definition Cotton pledget applicator, single-use A slender rod of wood, flexible metal, or synthetic material with a pledget of cotton attached at one end intended to be used for cleaning or applying a substance (e.g., medication) to superficial wounds or body orifices [e.g., ears, nose, oral cavity, throat, anus, rectum]. 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 Manufacturing 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#