Identity
- Trade Name
- AED Solar 2010 Portable LED Light Source FDA UDI
- Generic Name
- Operating room light FDA UDI
- Device Name
- The device is 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. It consists of an individual light head with more than one light source includes light-emitting diodes (LEDs) and a mechanism to adjust the focus. This device is portableand is 5 Watt powered. FDA UDI
- Model / Reference
- Solar 2010 FDA UDI
- Description
- The device is 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. It consists of an individual light head with more than one light source includes light-emitting diodes (LEDs) and a mechanism to adjust the focus. This device is portableand is 5 Watt powered. FDA UDI
Identifiers
- Catalog Number
- Solar 2010 FDA UDI
- Primary DI / UDI-DI
- 00848657086677 FDA UDI
- FDA Product Code
- NTN FDA UDI
- GMDN Term
- Operating room light FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Operating room light
AED Solar 2010 Portable LED Light Source by National Advanced Endoscopy Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Medical Boom — Amico Clinical Solutions Corp · Class II
- iCE Surgical Light — Amico Clinical Solutions Corp · Class II
- HarmonyAIR — STERIS CORPORATION · Class II
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
- National Advanced Endoscopy Devices, Inc.
Sources (1)
- FDA UDI db2c45a3-c4c1-4786-a7eb-2181a4e62261 35 fields · synced Jun 8, 2026