Identity
- Trade Name
- Vistor PRO LED FDA UDI
- Generic Name
- Transportable medical equipment stand, non-powered FDA UDI
- Device Name
- MI-1000 Minor Surgical Light, Floor Stand with Battery Back-up FDA UDI
- Model / Reference
- NV061513B FDA UDI
- Description
- MI-1000 Minor Surgical Light, Floor Stand with Battery Back-up FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816835020409 FDA UDI
- 510(k) Number
- K100388 FDA UDI
- FDA Product Code
- FST FDA UDI
- GMDN Term
- Transportable medical equipment stand, non-powered 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: Mobile examination/treatment room lightTransportable medical equipment stand, non-powered
Vistor PRO LED by Medical Illumination International, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Transportable medical equipment stand, non-powered.
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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 dc6c69ad-6d2a-4d0f-b7c0-b9d8f9baf550 34 fields · synced May 30, 2026