Identity
- Trade Name
- LEVEL ONE THORACIC FDA UDI
- Generic Name
- Sternal fixation device FDA UDI
- Device Name
- STERNAL TALON, SINGLE FOOT, EXTRA LARGE, TI-6AL-4V FDA UDI
- Model / Reference
- 24-012-20-09 FDA UDI
- Description
- STERNAL TALON, SINGLE FOOT, EXTRA LARGE, TI-6AL-4V FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888118031341 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Sternal fixation device FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Level One Thoracic by KLS-Martin L.P. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- KLS-Martin L.P.
Sources (1)
- FDA UDI 613d6f3e-4f94-480c-bcfb-4a3363c3815f 36 fields · synced Jun 7, 2026