FDA UDI
Not in Commercial Distribution
🇺🇸 United States
GRU Tibia
DI: 09340499005225
·
Model: GRU-0T-9.5-P-R
·
GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GRU Tibia
- Primary DI
- 09340499005225
- Version / Model
- GRU-0T-9.5-P-R
- Catalog Number
- GRU-0T-9.5-P-R
- 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
- 2016-03-23
- Public Version
- 4
- Public Version Date
- 2021-07-14
- Public Version Status
- Update
- Public Device Record Key
- a061ea4a-b283-464e-9446-58af6e7be613
- Distribution End Date
- 2021-07-14
Device Description
GRU Tibia Size 0 9.5mm
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 |
|---|---|---|---|---|
| 48069 | Uncoated unicondylar knee tibia prosthesis, polyethylene | A sterile implantable device designed to replace the bearing surface of one tibial condyle (tibial component) during primary or revision unicompartmental replacement of the knee joint. It is made of polyethylene (PE) and is not coated with a material intended to improve fixation and stability. The device articulates with a femoral component, 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 | 09340499005225 | 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 0 |