Identity
- Trade Name
- IsoLED Plus+ LED HL FDA UDI
- Generic Name
- Head-worn lamp FDA UDI
- Device Name
- IsoLED Plus+ LED HL, w/ AC Power Pack, Carrying Case FDA UDI
- Model / Reference
- IL-2410-03 FDA UDI
- Description
- IsoLED Plus+ LED HL, w/ AC Power Pack, Carrying Case FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816835024049 FDA UDI
- FDA Product Code
- HPP FDA UDI
- GMDN Term
- Head-worn lamp FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4335 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: Head-worn lamp
IsoLED Plus+ LED HL 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 ce51459c-edbb-4d8f-9074-bda0fa4d0a01 33 fields · synced Jun 8, 2026