Identity
- Trade Name
- Hintermann Series FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Cortical Screwdriver Instrument FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Cortical Screwdriver Instrument FDA UDI
Identifiers
- Catalog Number
- 309600 FDA UDI
- Primary DI / UDI-DI
- B095309600 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
- 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
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
Hintermann Series by Dt Medtech, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Dt Medtech, LLC
Sources (1)
- FDA UDI b3001e93-a782-4b63-ac6e-764f42231d40 37 fields · synced May 31, 2026