FDA UDI
In Commercial Distribution
🇺🇸 United States
restor3d Total Talus Replacement
DI: 00840097509891
·
Model: 6102-600
·
Restor3d, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- restor3d Total Talus Replacement
- Primary DI
- 00840097509891
- Version / Model
- 6102-600
- Company Name
- Restor3d, Inc.
- Labeler DUNS
- 080819836
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-15
- Public Version
- 1
- Public Version Date
- 2024-03-25
- Public Version Status
- New
- Public Device Record Key
- 824dd059-c91f-41e1-bfc3-1531e10af05b
Device Description
Impactor, Flat
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
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QNN | Prosthesis, Total Talus Replacement, Metal | Unknown | f | |
| QYQ | Prosthesis, Total Talus Replacement With Soft Tissue Attachment Sites, Metal | Unknown | f |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66297 | Custom-made hand/foot bone prosthesis | An implantable device designed and created for a specific patient to replace the whole or part of a bone in the hand or foot, including the wrist or ankle (e.g., carpal, metacarpal, tarsal or metatarsal bones), typically to treat avascular necrosis or other osteolytic conditions. It is made of metal [e.g., titanium (Ti) alloy]. Devices intended to assist implantation (e.g., trial prosthesis, surgical guide) may be included with the prosthesis. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840097509891 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| H230003 | 000 |