Identity
- Trade Name
- TSI FDA UDI
- Generic Name
- Orthopaedic joint/limb rongeur FDA UDI
- Device Name
- 8" KERRISON, 5 MM, 15 MM OPEN, BLACK FDA UDI
- Model / Reference
- KR-1315B FDA UDI
- Description
- 8" KERRISON, 5 MM, 15 MM OPEN, BLACK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843059109993 FDA UDI
- FDA Product Code
- HTX FDA UDI
- GMDN Term
- Orthopaedic joint/limb rongeur FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic joint/limb rongeur
Tsi by Tedan Surgical Innovations, L.l.c. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic joint/limb rongeur.
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- Hayden Medical — Hayden Medical Inc · Class I
- MICRO FRIEDMAN RONGEUR — SONTEC INSTRUMENTS, INC. · Class I
- Sklar® — Sklar Corporation · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Tedan Surgical Innovations, L.l.c.
Sources (1)
- FDA UDI 81fe1b34-c999-49aa-b7ce-1514ed434d8d 33 fields · synced Jun 8, 2026