Identity
- Trade Name
- Elos Driver FDA UDI
- Generic Name
- Surgical torque wrench adaptor FDA UDI
- Device Name
- A driver for a dental torque wrench for placement and adjustment of dental implants, abutments, abutment screw and prosthetic screws during oral surgery and prosthetic procedures. FDA UDI
- Model / Reference
- C19356 FDA UDI
- Description
- A driver for a dental torque wrench for placement and adjustment of dental implants, abutments, abutment screw and prosthetic screws during oral surgery and prosthetic procedures. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05712821007513 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Surgical torque wrench adaptor FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Elos Driver by Elos Medtech Pinol A/S — 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
- Elos Medtech Pinol A/S
Sources (1)
- FDA UDI 8954a7fb-4e47-4c23-980b-e2fb04ec1352 34 fields · synced Jun 1, 2026