Identity
- Trade Name
- Power Dental USA FDA UDI
- Generic Name
- Tumour-therapy nanoparticle suspension, magnetic hyperthermia/thermoablation FDA UDI
- Device Name
- MIRROR WITH MIRROR HANDLE #4 MIRROR C/S FRONT SURFACE WITH MIRROR HANDLE 6EZ C/S (6950+6911) FOR USE ONLY WITH POWER DUSA MIRRORS/HANDLES. WE DO NOT GUARANTEE FIT OF OTHER MANUFACTURERS MIRRORS/HANDLES FDA UDI
- Model / Reference
- 6967 FDA UDI
- Description
- MIRROR WITH MIRROR HANDLE #4 MIRROR C/S FRONT SURFACE WITH MIRROR HANDLE 6EZ C/S (6950+6911) FOR USE ONLY WITH POWER DUSA MIRRORS/HANDLES. WE DO NOT GUARANTEE FIT OF OTHER MANUFACTURERS MIRRORS/HANDLES FDA UDI
Identifiers
- Catalog Number
- 6967 FDA UDI
- Primary DI / UDI-DI
- D9436967 FDA UDI
- FDA Product Code
- FTX FDA UDI
- GMDN Term
- Tumour-therapy nanoparticle suspension, magnetic hyperthermia/thermoablation 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
Yes
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
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 USA 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 f830cd74-d11d-4bb1-bf2f-a08df0c6c06a 36 fields · synced May 30, 2026