Identity
- Trade Name
- Torque Limiter FDA UDI
- Generic Name
- Surgical instrument torque limiter FDA UDI
- Model / Reference
- 85836 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290115934151 FDA UDI
- 510(k) Number
- K182598 FDA UDI
- FDA Product Code
- NKB FDA UDI
- GMDN Term
- Surgical instrument torque limiter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 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
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
Category: Surgical instrument torque limiter
Torque Limiter by Premia Spine Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K182598 also covers:
- Cannulated Pedicle Awl — PREMIA SPINE LTD
- Cannulated Screwdriver — PREMIA SPINE LTD
- Cannulated Tap Ø 6.5 mm — PREMIA SPINE LTD
- Compressor — PREMIA SPINE LTD
- Distractor — PREMIA SPINE LTD
- Inner Dilator — PREMIA SPINE LTD
- K-Wire, Blunt Sharp Tip, L=335, Ø1.7mm KWA — PREMIA SPINE LTD
- MIS Cannulated Pedicle Probe — PREMIA SPINE LTD
- MIS Compressor — PREMIA SPINE LTD
- Niti#1 Wire, Blunt Blunt Tip, L=470, Ø1.7mm Over K-Wire — PREMIA SPINE LTD
- Pendulum — PREMIA SPINE LTD
- Ratchet T Handle — PREMIA SPINE LTD
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
- Premia Spine Ltd
Sources (1)
- FDA UDI 21c0152e-762b-4939-81e4-2992e97d170c 33 fields · synced May 29, 2026