Identity
- Trade Name
- TorqLoc Instrument FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- TorqLoc Large handle, cannulated, quick coupling FDA UDI
- Model / Reference
- OP-ISC-9013 FDA UDI
- Description
- TorqLoc Large handle, cannulated, quick coupling FDA UDI
Identifiers
- Catalog Number
- OP-ISC-9013 FDA UDI
- Primary DI / UDI-DI
- E302OPISC90139 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
TorqLoc Instrument by Bioretec Oy — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Bioretec Oy
Sources (1)
- FDA UDI b7510e61-06f7-475c-a958-69f562770743 36 fields · synced May 29, 2026