Home GUDID 00681490035408 Fischer Sprandel II
Primary DI 00681490035408
Brand Fischer Sprandel II
Company MEDTRONIC XOMED, INC.
Model 1156295
Device description PROSTHESIS 1156295 FISCH SPANDREL II TOT
Published 2015-07-01
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety MR Conditional
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name LBN REPLACEMENT, TOTAL OSSICULAR, PROSTHESIS, POROUS, POLYETHYLENE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LBN Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene Ear, Nose, Throat 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00681490035408 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 00681490035408 00681490035408 681490035408 0681490035408
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 Device Size Text, specify 0 Length 6.75 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 00763000913687 Brackmann/Polycel MEDTRONIC XOMED, INC. LBN 2025-06-23 00763000035372 Moretz / Polycel® MEDTRONIC XOMED, INC. LBN 2021-11-07 00763000035389 Brackmann / Polycel® MEDTRONIC XOMED, INC. LBN 2021-11-07 00681490035415 Mortez MEDTRONIC XOMED, INC. LBN 2015-07-01 00681490035422 Mortez MEDTRONIC XOMED, INC. LBN 2015-07-01 00681490035439 Mortez MEDTRONIC XOMED, INC. LBN 2015-07-01 00681490035446 Mortez MEDTRONIC XOMED, INC. LBN 2015-07-01 00681490035453 Brackmann MEDTRONIC XOMED, INC. LBN 2015-07-01 00681490035460 Moretz MEDTRONIC XOMED, INC. LBN 2015-07-01
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