DEVICE: Unitrax (07613327032451)
Device Identifier (DI) Information
Unitrax
6942-5-051
In Commercial Distribution
6942-5-051
Howmedica Osteonics Corp.
6942-5-051
In Commercial Distribution
6942-5-051
Howmedica Osteonics Corp.
Head Component
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? |
---|---|---|---|---|
34223 | Uncoated hip femur prosthesis, one-piece |
A sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck; the device is one-piece and is not coated with materials intended to improve fixation and stability. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation is intended to be performed with bone cement.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KWL | Prosthesis, hip, hemi-, femoral, metal |
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 |
---|
Outer Diameter: 51.0 Millimeter |
Device Record Status
bf42ff6e-51e5-4dc6-a562-f78fc3a27b73
February 07, 2023
4
September 24, 2015
February 07, 2023
4
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