Identity
- Trade Name
- Maquet PowerLED II FDA UDI
- Generic Name
- Operating room light FDA UDI
- Device Name
- PWDII70DF VP AIM CL XS3216 K3 1011 FDA UDI
- Model / Reference
- ARDPWT259283A FDA UDI
- Description
- PWDII70DF VP AIM CL XS3216 K3 1011 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03700712414665 FDA UDI
- FDA Product Code
- FTD FDA UDI
- GMDN Term
- Operating room light FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4580 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
A device designed to provide a specialized source of light for illumination of a site of medical intervention. It provides a high intensity, high colour rendering field of light that minimizes shadows and the emission of heat.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Maquet, Inc.
Sources (1)
- FDA UDI 17a2b241-9ae0-444e-b068-d1b60e6ea001 35 fields · synced Jul 8, 2026