Identity
- Trade Name
- Screwdriver, Hexagonal, Cannulated FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Model / Reference
- 110211000 FDA UDI
Identifiers
- Catalog Number
- 110211000 FDA UDI
- Primary DI / UDI-DI
- 06902139111395 FDA UDI
- 510(k) Number
- K130108 FDA UDI
- FDA Product Code
- HRS FDA UDIHWC FDA UDI
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI888.3040 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 screwdriver, reusable
Screwdriver, Hexagonal, Cannulated by Double Medical Technology Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical screwdriver, reusable.
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- USS — Synthes · Class I
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class I
- CosmoLock Pedicle Screw System — Kalitec Direct LLC · Class I
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 79b6d269-d830-443c-8122-9b7363b11387 35 fields · synced Jun 8, 2026