DEVICE: MEDPOR (07613252085041)
Device Identifier (DI) Information
MEDPOR
8330
In Commercial Distribution
8330
Stryker Leibinger GmbH & Co. KG
8330
In Commercial Distribution
8330
Stryker Leibinger GmbH & Co. KG
Ear Base Extended - Right
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Ear prosthesis | A sterile device intended to be 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). |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FWP | PROSTHESIS, CHIN, INTERNAL |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Width: 30.0 Millimeter |
Length: 59.0 Millimeter |
Device Record Status
e7bc8163-617c-4615-abcc-445b1798bbcc
March 29, 2018
2
September 24, 2015
March 29, 2018
2
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 |
---|---|
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