Identity
- Trade Name
- SYSTEM TWO LED FDA UDI
- Generic Name
- Operating room light system FDA UDI
- Device Name
- SYSTEM TWO LED, DUO, IL0CR & SURG LIGHT FDA UDI
- Model / Reference
- SD2CD2-LCH FDA UDI
- Description
- SYSTEM TWO LED, DUO, IL0CR & SURG LIGHT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816835023660 FDA UDI
- 510(k) Number
- K100388 FDA UDI
- FDA Product Code
- FST FDA UDI
- GMDN Term
- Operating room light system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4580 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Operating room light system
System Two Led by Medical Illumination International, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K100388 also covers:
- MAXX LUXX LED — Avante
- MAXX LUXX LED — Avante
- MAXX LUXX LED — Avante
- MAXX LUXX LED — Avante
- MAXX LUXX LED — Avante
- MAXX LUXX LED — Avante
- MAXX LUXX LED — Avante
- MAXX LUXX LED — Avante
- VISION LED — Avante
- MI Product Line — Medical Illumination International, Inc
- MI Product Line — Medical Illumination International, Inc
- MI Product Line — Medical Illumination International, Inc
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
- Medical Illumination International, Inc
Sources (1)
- FDA UDI 6c26c0e2-d1da-4a56-b060-a2c081ed9f5d 34 fields · synced Jun 8, 2026