Home GUDID 00821925014176 GYRUS ACMI, INC
Primary DI 00821925014176
Brand GYRUS ACMI, INC
Company Gyrus ACMI, LLC
Model 140087
Device description FISCH TORP PROSTHESIS .8 MM SHAFT DIAMETER 8 MM LENGTH PLASTI-PORE
Published 2015-10-24
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 ETA Replacement, Ossicular Prosthesis, Total
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ETA Replacement, Ossicular Prosthesis, Total Ear, Nose, Throat 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00821925014176 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 00821925014176 00821925014176 821925014176 0821925014176
GMDN Terms# Term, Definition table Term Definition Ossicular prosthesis, total A sterile device intended to be implanted for the total functional reconstruction of the ossicular chain (mallues, incus, and stapes bones) to facilitate the conduction of sound waves from the tympanic membrane to the inner ear. It is designed to treat conductive hearing loss from traumatic or surgical injury, otosclerosis, congenital fixation of the stapes, or chronic middle ear disease. The device is typically in the form of a tube made of polymers.
Regulatory Flags# DUNS number 007198742 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 false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00821925013964 GYRUS ACMI, INC 140003 2015-10-24 00821925014039 EVONOS GMBH & Co. Kg 140053 2015-10-24 00821925014060 EVONOS GMBH & Co. Kg 140059 2015-10-24 00821925014190 GYRUS ACMI, INC 140102 2015-10-24 00821925014497 GYRUS ACMI, INC 140103 2015-10-24 00821925014534 GYRUS ACMI, INC 140070 2015-10-24 00821925015449 Gyrus ACMI 140181 2015-10-24 00821925015470 Gyrus ACMI 140185 2015-10-24 00821925015487 Gyrus ACMI 140186 2015-10-24 00821925015500 GYRUS ACMI, INC 140188 2015-10-24 00821925016057 Gyrus ACMI 140164 2015-10-24 00821925016064 Gyrus ACMI 140165 2015-10-24 00821925016071 Gyrus ACMI 140166 2015-10-24 00821925016088 Gyrus ACMI 140167 2015-10-24 00821925016095 GYRUS ACMI, INC 140168 2015-10-24 00821925016125 Gyrus ACMI 140180 2015-10-24 00821925016934 GYRUS ACMI, INC 140149 2015-10-24 00821925016965 Gyrus ACMI 140162 2015-10-24 00821925017207 GYRUS ACMI, INC 140108 2015-10-24 00821925017535 GYRUS ACMI, INC 140116 2015-10-24
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00844505014663 OFFSET TITANIUM WILDCAT ALTO Grace Medical, Inc. ETA 2025-07-17 00763000913489 N/A MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000913496 Bojrab MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000913502 Causse/Polycel MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000913519 Flex H/A MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000913526 Flex H/A MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000913533 Flex H/A MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000913540 Causse/Flex H/A MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000913557 Flex H/A MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000913564 Flex H/A MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000913571 Causse/Vincent MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000913595 Flex H/A MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000913601 Flex H/A MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000913625 N/A MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000913632 N/A MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000913649 N/A MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000913656 N/A MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000913663 Silverstein MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000913717 Sheehy/Polycel MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000913724 Sheehy/Polycel MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000913731 N/A MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000913762 N/A MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000033385 HA/C Polycel® Brackmann Total MEDTRONIC XOMED, INC. ETA 2024-05-12 00763000034832 Sheehy HA/C Polycel® P.O.P. MEDTRONIC XOMED, INC. ETA 2024-05-12 00763000034849 Sheehy HA/C Polycel® T.O.P. MEDTRONIC XOMED, INC. ETA 2024-05-12 00763000036591 Big Easy® Piston MEDTRONIC XOMED, INC. ETA 2024-05-12 00763000036607 Big Easy® Piston MEDTRONIC XOMED, INC. ETA 2024-05-12 00763000036614 Big Easy® Piston MEDTRONIC XOMED, INC. ETA 2024-05-12 00763000036621 Big Easy® Piston MEDTRONIC XOMED, INC. ETA 2024-05-12 00763000036638 Big Easy® Piston MEDTRONIC XOMED, INC. ETA 2024-05-12
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