DEVICE: MEDPOR (07613252085058)
Device Identifier (DI) Information
MEDPOR
8331
In Commercial Distribution
8331
Stryker Leibinger GmbH & Co. KG
8331
In Commercial Distribution
8331
Stryker Leibinger GmbH & Co. KG
Ear Base Extended - Left
Device Characteristics
Labeling does not contain MRI Safety Information | |
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? |
---|---|---|---|---|
35262 | External ear prosthesis, implantable |
A device intended to be fully- or partially- implanted to reconstruct the external ear by replacing damaged or missing tissue. It is typically made of a polymer material (e.g., solid silicone rubber).
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FWP | PROSTHESIS, CHIN, INTERNAL |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K922489 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Width: 30.0 Millimeter |
Length: 59.0 Millimeter |
Device Record Status
f1dc1b85-ba59-4945-b726-ff7bffd506de
July 22, 2021
5
September 24, 2015
July 22, 2021
5
September 24, 2015
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 |
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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
[?]
No Customer Contact currently defined