Identity
- Trade Name
- Power Dental U.S.A., Inc. FDA UDI
- Generic Name
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- 2 LED HANDPIECE, STERILIZABLE ALL IN ONE, COMPLETE WITH CORDS FDA UDI
- Model / Reference
- N8001S FDA UDI
- Description
- 2 LED HANDPIECE, STERILIZABLE ALL IN ONE, COMPLETE WITH CORDS FDA UDI
Identifiers
- Catalog Number
- N8001S FDA UDI
- Primary DI / UDI-DI
- D943N8001S00 FDA UDI
- FDA Product Code
- MDM FDA UDI
- GMDN Term
- Dental/maxillofacial surgical procedure kit, non-medicated, 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Power Dental U.S.A., Inc. by Power Dental USA, Inc. — 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
- Power Dental USA, Inc.
Sources (1)
- FDA UDI e7131c99-b9dd-4277-b96f-af4c6ca8a4e5 36 fields · synced May 30, 2026