Home GUDID 00821925022546 Gyrus ACMI
Primary DI 00821925022546
Brand Gyrus ACMI
Company Gyrus ACMI, LLC
Model 70921337
Device description MCMURRY MODIFIED PISTON PLATINUM
Published 2016-10-06
Public version status Update
Distribution status Not 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 ETB PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ETB Prosthesis, Partial Ossicular Replacement Ear, Nose, Throat 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00821925022546 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 00821925022546 00821925022546 821925022546 0821925022546
GMDN Terms# Term, Definition table Term Definition Ossicular prosthesis, partial A sterile device intended to be implanted for the functional reconstruction of segments of the ossicular chain (mallues, incus, and/or 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 metal [e.g., stainless steel, titanium (Ti)], polymers, or a combination of these materials.
Regulatory Flags# DUNS number 007198742 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00844505010269 TITANIUM/FLUOROPLASTIC PISTON Grace Medical, Inc. ETB 2026-02-03 00844505014526 GRACE PISTON Grace Medical, Inc. ETB 2026-01-07 00844505014533 GRACE PISTON Grace Medical, Inc. ETB 2026-01-07 00844505014540 GRACE PISTON Grace Medical, Inc. ETB 2026-01-07 00844505014502 TITANIUM PISTON Grace Medical, Inc. ETB 2025-09-18 00844505014687 GRACE MEDICAL FLUOROPLASTIC PISTON Grace Medical, Inc. ETB 2025-09-18 00844505014489 ECLIPSE PISTON Grace Medical, Inc. ETB 2025-08-05 00844505014519 TITANIUM PISTON Grace Medical, Inc. ETB 2025-08-05 00844505014564 GRACE MEDICAL FLUOROPLASTIC PISTON Grace Medical, Inc. ETB 2025-08-05 00844505014670 GRACE MEDICAL FLUOROPLASTIC PISTON Grace Medical, Inc. ETB 2025-08-05 00844505014649 NYTEBYTE Grace Medical, Inc. ETB 2025-07-02 00763000913731 N/A MEDTRONIC XOMED, INC. ETB 2025-06-23 00821925035478 Gyrus ACMI Gyrus ACMI, LLC ETB 2024-07-25 00763000036591 Big Easy® Piston MEDTRONIC XOMED, INC. ETB 2024-05-12 00763000036607 Big Easy® Piston MEDTRONIC XOMED, INC. ETB 2024-05-12 00763000036614 Big Easy® Piston MEDTRONIC XOMED, INC. ETB 2024-05-12 00763000036621 Big Easy® Piston MEDTRONIC XOMED, INC. ETB 2024-05-12 00763000036638 Big Easy® Piston MEDTRONIC XOMED, INC. ETB 2024-05-12 00763000036645 Big Easy® Piston MEDTRONIC XOMED, INC. ETB 2024-05-12 EHKM10022601 CliP Partial Prosthesis Titanium Heinz Kurz GmbH ETB 2023-09-29 EHKM10022641 CliP Partial Prosthesis Titanium Heinz Kurz GmbH ETB 2023-09-29 EHKM10022661 CliP Partial Prosthesis Titanium Heinz Kurz GmbH ETB 2023-09-29 EHKM10022681 CliP Partial Prosthesis Titanium Heinz Kurz GmbH ETB 2023-09-29 EHKM10022701 CliP Partial Prosthesis Titanium Heinz Kurz GmbH ETB 2023-09-29 EHKM10022721 CliP Partial Prosthesis Titanium Heinz Kurz GmbH ETB 2023-09-29 EHKM10022731 CliP Partial Prosthesis Titanium Heinz Kurz GmbH ETB 2023-09-29 EHKM10022741 CliP Partial Prosthesis Titanium Heinz Kurz GmbH ETB 2023-09-29 EHKM10023641 CliP Partial FlexiBAL Titanium Heinz Kurz GmbH ETB 2023-09-29 EHKM10023661 CliP Partial FlexiBAL Titanium Heinz Kurz GmbH ETB 2023-09-29 EHKM10023681 CliP Partial FlexiBAL Titanium Heinz Kurz GmbH ETB 2023-09-29