Identity
- Trade Name
- Torque Limiter 0.4 N-m FDA UDI
- Generic Name
- Surgical instrument torque limiter FDA UDI
- Model / Reference
- 111304200 FDA UDI
Identifiers
- Catalog Number
- 111304200 FDA UDI
- Primary DI / UDI-DI
- 06902139112484 FDA UDI
- 510(k) Number
- K130108 FDA UDI
- FDA Product Code
- HWC FDA UDIHRS FDA UDI
- GMDN Term
- Surgical instrument torque limiter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI888.3030 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 0.4 N-m by Double Medical Technology Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K130108 also covers:
- 1.5S-Mini Screw — Double Medical Technology Inc.
- 2.0S-Mini Screw — Double Medical Technology Inc.
- 2.4mm Locking Screw — Double Medical Technology Inc.
- 2.7S-Mini Locking Screw — Double Medical Technology Inc.
- 2.7S-Mini Screw — Double Medical Technology Inc.
- 2.7S-Mini Screw — Double Medical Technology Inc.
- 2.7S-Mini Screw — Double Medical Technology Inc.
- 3.5mm Locking Screw, Self-drilling — Double Medical Technology Inc.
- 4.0mm Cancellous Screw, Fully Threaded — Double Medical Technology Inc.
- 5.0mm Locking screw, Self-drilling — Double Medical Technology Inc.
- 5.0mm Locking screw, Self-drilling — Double Medical Technology Inc.
- 5.0mm Locking screw, Self-tapping — Double Medical Technology Inc.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Double Medical Technology Inc.
Sources (1)
- FDA UDI 62e1b47c-b1e5-4ced-8a57-413ff4ac907a 35 fields · synced May 31, 2026