FDA UDI
In Commercial Distribution
🇺🇸 United States
11mm STAR E+ Sliding Core STAR Total Ankle
DI: 00810028393523
·
Model: 602-03-011
·
Trilliant Surgical, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 11mm STAR E+ Sliding Core STAR Total Ankle
- Primary DI
- 00810028393523
- Version / Model
- 602-03-011
- Company Name
- Trilliant Surgical, LLC
- Labeler DUNS
- 828829072
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-06
- Public Version
- 1
- Public Version Date
- 2024-08-14
- Public Version Status
- New
- Public Device Record Key
- ed05bd16-602d-4c1f-99dc-1f568845ca34
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| NTG | Prosthesis, Ankle, Uncemented, Non-Constrained | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48180 | Ankle prosthesis bearing | A sterile implantable device made of polyethylene (PE) designed to articulate the tibial and talar components of a total ankle prosthesis. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810028393523 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P050050 | 024 |