Home GUDID 00763000035143 N/A
Primary DI 00763000035143
Brand N/A
Company MEDTRONIC XOMED, INC.
Model 1133008
Device description PROSTHESIS 1133008 CUP PISTON .4X4.5 SST
Published 2021-06-17
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Conditional
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 00763000035143 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 00763000035143 00763000035143 763000035143 0763000035143
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.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Device Size Text, specify 0 Length 4.5 Millimeter
Regulatory Flags# DUNS number 835465063 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false 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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