Identity
- Trade Name
- MI-1000CAM FDA UDI
- Generic Name
- Operating room light FDA UDI
- Device Name
- MI-1000, Dual Ceiling Mount, with Camera Option FDA UDI
- Model / Reference
- 061525CAM FDA UDI
- Description
- MI-1000, Dual Ceiling Mount, with Camera Option FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816835024339 FDA UDI
- 510(k) Number
- K100388 FDA UDI
- FDA Product Code
- FST FDA UDI
- GMDN Term
- Operating room light 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
No
FDA UDI
Category: Operating room light
Mi-1000cam by Medical Illumination International, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Operating room light.
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- Medical Boom — Amico Clinical Solutions Corp · Class II
- HarmonyAIR — STERIS CORPORATION · Class II
- HarmonyAIR — STERIS CORPORATION · Class II
- Medical Boom — Amico Clinical Solutions Corp · Class II
- iCE Surgical Light — Amico Clinical Solutions Corp · Class II
- HarmonyAIR — STERIS CORPORATION · Class II
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 15e217e6-24a2-489c-8b0b-7b8e98eedbf6 34 fields · synced May 30, 2026