Home GUDID 00763000036201 Flex H/A®
Primary DI 00763000036201
Brand Flex H/A®
Company MEDTRONIC XOMED, INC.
Model 1150001
Device description PROSTHESIS 1150001 UNIV TITAN CAM HEAD
Published 2021-11-07
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name ETA REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL ETB PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ETA Replacement, Ossicular Prosthesis, Total Ear, Nose, Throat 2 ETB Prosthesis, Partial Ossicular Replacement Ear, Nose, Throat 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00763000036201 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 00763000036201 00763000036201 763000036201 0763000036201
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.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Length 10 Millimeter
Regulatory Flags# DUNS number 835465063 Device count 1 Lot or batch 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 00844505014663 OFFSET TITANIUM WILDCAT ALTO Grace Medical, Inc. ETA 2025-07-17 00844505014649 NYTEBYTE Grace Medical, Inc. ETB 2025-07-02 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
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