Identity
- Trade Name
- Hintermann Series FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Screw driver hex FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Screw driver hex FDA UDI
Identifiers
- Catalog Number
- 319645 FDA UDI
- Primary DI / UDI-DI
- B095319645 FDA UDI
- 510(k) Number
- K171004 FDA UDI
- FDA Product Code
- LRZ FDA UDI
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
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
Hintermann Series by Dt Medtech, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical screwdriver, reusable.
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- LOSPA IS Spinal Fixation System — Corentec Co., Ltd · Class II
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- USS — Synthes · Class I
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class I
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Cleared under the same submission
K171004 also covers:
- Hintermann Series — Dt Medtech, LLC
- Hintermann Series — Dt Medtech, LLC
- Hintermann Series — Dt Medtech, LLC
- Hintermann Series — Dt Medtech, LLC
- Hintermann Series — Dt Medtech, LLC
- Hintermann Series — Dt Medtech, LLC
- Hintermann Series — Dt Medtech, LLC
- Hintermann Series — Dt Medtech, LLC
- Hintermann Series — Dt Medtech, LLC
- Hintermann Series — Dt Medtech, LLC
- Hintermann Series — Dt Medtech, LLC
- Hintermann Series — Dt Medtech, LLC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dt Medtech, LLC
Sources (1)
- FDA UDI 2a8e77bd-a8f3-4eb7-8053-99bebffc78ce 36 fields · synced Jun 6, 2026