Identity
- Trade Name
- IA-40 H Drive Handpiece FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Drive Handpiece for Prosthodontic Screwdriver FDA UDI
- Model / Reference
- 16834000 FDA UDI
- Description
- Drive Handpiece for Prosthodontic Screwdriver FDA UDI
Identifiers
- Primary DI / UDI-DI
- J021168340001 FDA UDI
- FDA Product Code
- EKX FDA UDI
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4200 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical screwdriver, reusable
IA-40 H Drive Handpiece by W & H Dentalwerk Bürmoos GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- W & H Dentalwerk Bürmoos GmbH
Sources (1)
- FDA UDI 40e8f7de-d9ff-485d-a0f9-2860fc8a7e2a 33 fields · synced May 30, 2026