FDA UDI
Not in Commercial Distribution
🇺🇸 United States
RBK Patello Femoral
DI: 09340499022703
·
Model: GO-6000-4PFL-01
·
GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RBK Patello Femoral
- Primary DI
- 09340499022703
- Version / Model
- GO-6000-4PFL-01
- Catalog Number
- GO-6000-4PFL-01
- 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
- 5
- Public Version Date
- 2021-07-14
- Public Version Status
- Update
- Public Device Record Key
- 4191ef15-a988-4c58-8a9a-49c78c7789e2
- Distribution End Date
- 2021-07-14
Device Description
RBK Patello Femoral Size 4 Left
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 |
|---|---|---|---|---|
| KRR | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | Orthopedic | 888.3540 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32831 | Uncoated knee femur prosthesis, metallic | An implantable device designed to replace the femoral condyles (femoral component) during primary bicondylar replacement of the knee joint, femoral bone resection, or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo), titanium (Ti)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with tibial and, if required, patellar prosthetic components of the knee joint 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 | 09340499022703 | GS1 |
Customer Contacts
- Phone
- +6128870100
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K050473 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Size 4 |