Identity
- Trade Name
- IsoLED Flex I LED Exam Light FDA UDI
- Generic Name
- Mobile examination/treatment room light FDA UDI
- Device Name
- IsoLED Flex I LED Examination Light, Surgical Table Rail Mount FDA UDI
- Model / Reference
- IL-2501 FDA UDI
- Description
- IsoLED Flex I LED Examination Light, Surgical Table Rail Mount FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816835024261 FDA UDI
- FDA Product Code
- KYT FDA UDI
- GMDN Term
- Mobile examination/treatment room light FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6350 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
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
Category: Mobile examination/treatment room light
IsoLED Flex I LED Exam Light by Medical Illumination International, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Medical Illumination International, Inc
Sources (1)
- FDA UDI 5623fd4c-7a52-4c0d-a391-da464fee555c 33 fields · synced May 31, 2026