Home GUDID 00821925014206 Gyrus ACMI
Primary DI 00821925014206
Brand Gyrus ACMI
Company Gyrus ACMI, LLC
Model 140420
Device description SHEA CUP PISTON SMALL, RIGHT 4 MM LENGTH FLUOROPLASTIC
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 00821925014206 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 00821925014206 00821925014206 821925014206 0821925014206
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# 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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