FDA UDI
In Commercial Distribution
🇺🇸 United States
Oxford Partial Knee System
DI: 05019279347018
·
Model: 32-422718
·
Biomet Uk Ltd
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Oxford Partial Knee System
- Primary DI
- 05019279347018
- Version / Model
- 32-422718
- Catalog Number
- 32-422718
- Company Name
- Biomet Uk Ltd
- Labeler DUNS
- 219322575
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-08-29
- Public Version
- 9
- Public Version Date
- 2022-09-21
- Public Version Status
- Update
- Public Device Record Key
- b61cc3ee-4616-4ef4-8cd8-220e0ca3d8c0
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NRA | Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12696 | Orthopaedic implant inserter/extractor, reusable | A hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05019279347018 | GS1 |
Customer Contacts
- Phone
- 1-800-348-9500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P010014 | 000 |
| P010014 | 001 |
| P010014 | 004 |
| P010014 | 005 |
| P010014 | 006 |
| P010014 | 009 |
| P010014 | 015 |
| P010014 | 016 |
| P010014 | 018 |
| P010014 | 020 |
| P010014 | 021 |
| P010014 | 024 |
| P010014 | 027 |
| P010014 | 028 |
| P010014 | 030 |
| P010014 | 031 |
| P010014 | 032 |
| P010014 | 033 |
| P010014 | 035 |
| P010014 | 036 |
| P010014 | 037 |
| P010014 | 039 |
| P010014 | 048 |
| P010014 | 067 |