DEVICE: Fisch / Polycel® (00763000035402)
Device Identifier (DI) Information
Fisch / Polycel®
1156307
In Commercial Distribution
MEDTRONIC XOMED, INC.
1156307
In Commercial Distribution
MEDTRONIC XOMED, INC.
PROSTHESIS 1156307 FISCH TOTAL 8MM L
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
35674 | 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.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LBM | POROUS POLYETHYLENE OSSICULAR REPLACEMENT |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K823442 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Shaft Diameter = 0.6 mm |
Length: 8.0 Millimeter |
Device Size Text, specify: Head Diameter = 2.2 mm x 3 mm |
Device Record Status
afe122c3-e913-415e-88f5-6ff6b27d83d8
November 15, 2021
1
November 07, 2021
November 15, 2021
1
November 07, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
Corporate.UDI@medtronic.com