Identity
- Trade Name
- POWERLED TM FDA UDI
- Generic Name
- Operating room light FDA UDI
- Device Name
- PWD77+SF SHD K3 FDA UDI
- Model / Reference
- ARD568411255A FDA UDI
- Description
- PWD77+SF SHD K3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03700712403683 FDA UDI
- 510(k) Number
- K070442 FDA UDI
- FDA Product Code
- FSY 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
No
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
Powerled Tm by Maquet, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Maquet, Inc.
Sources (1)
- FDA UDI 9f4899d0-5849-439c-866d-ed46c3f69015 35 fields · synced May 31, 2026