FDA UDI
Not in Commercial Distribution
🇺🇸 United States
GRU Femur
DI: 09340499005539
·
Model: GRU-RM/LL-4F-C
·
GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GRU Femur
- Primary DI
- 09340499005539
- Version / Model
- GRU-RM/LL-4F-C
- Catalog Number
- GRU-RM/LL-4F-C
- Company Name
- GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
- Labeler DUNS
- 752039982
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-03-09
- Public Version
- 4
- Public Version Date
- 2021-07-14
- Public Version Status
- Update
- Public Device Record Key
- c2531c27-6abe-444d-b0ab-526f889f43a0
- Distribution End Date
- 2021-07-14
Device Description
GRU Femur RMLL Size 4
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | Orthopedic | 888.3530 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33369 | Uncoated unicondylar knee femur prosthesis | A sterile implantable device designed to replace the bearing surface of one femoral condyle (femoral component) during primary or revision unicompartmental replacement of the knee joint. It is made of metal [e.g., cobalt-chrome (Co-Cr)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. The device articulates with a tibial component and an insert, and its implantation is intended to be performed with bone cement. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09340499005539 | GS1 |
Customer Contacts
- Phone
- +6128870100
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K051721 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Size 4 |