Identity
- Trade Name
- VISION LED FDA UDI
- Generic Name
- Transportable medical equipment stand, non-powered FDA UDI
- Device Name
- DRE Vision LED, WALL MOUNT FDA UDI
- Model / Reference
- DRE 061512-V FDA UDI
- Description
- DRE Vision LED, WALL MOUNT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815871021685 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: Transportable medical equipment stand, non-powered
Vision Led by Avante — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Transportable medical equipment stand, non-powered.
- CIM med GmbH — CIM med GmbH · Class I
- GlideScope® — Verathon Medical (Canada) ULC · Class I
- AccuVein — Accuvein Inc. · Class I
- GlideScope® — Verathon Medical (Canada) ULC · Class I
- Trolly — EVENTUM ORTHOPAEDICS LTD · Class II
- CIM med GmbH — CIM med GmbH · Class I
- Aurora Surgical Light Series — Skytron, LLC · Class II
- Kangaroo — Cardinal Health 200, LLC · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Avante
Sources (1)
- FDA UDI 57fd48f5-b3b7-46fe-826e-e8d4d31acfad 34 fields · synced Jun 8, 2026