Identity
- Trade Name
- NvisionVLE Imaging Console Refurbished FDA UDI
- Generic Name
- Endoscopic optical coherence tomography system FDA UDI
- Model / Reference
- 94101-R FDA UDI
Identifiers
- Catalog Number
- 94101-R FDA UDI
- Primary DI / UDI-DI
- 00859591006096 FDA UDI
- 510(k) Number
- K143678 FDA UDI
- FDA Product Code
- NQQ FDA UDI
- GMDN Term
- Endoscopic optical coherence tomography system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 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
Yes
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: Endoscopic optical coherence tomography system
NvisionVLE Imaging Console Refurbished by Ninepoint Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Endoscopic optical coherence tomography system.
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- NvisionVLE Marking Console with IRIS — NINEPOINT MEDICAL, INC. · Class II
- NvisionVLE Marking Console with IRIS, Upgraded — NINEPOINT MEDICAL, INC. · Class II
- NvisionVLE Marking Upgrade Refurbished — NINEPOINT MEDICAL, INC. · Class II
- NvisionVLE Marking Console with IRIS, Refurbished — NINEPOINT MEDICAL, INC. · Class II
- NvisionVLE Marking Console Refurbished — NINEPOINT MEDICAL, INC. · Class II
Cleared under the same submission
K143678 also covers:
- NvisionVLE Imaging Console — NINEPOINT MEDICAL, INC.
- NvisionVLE Imaging Probe 14mm — NINEPOINT MEDICAL, INC.
- NvisionVLE Imaging Probe 14mm Clinical — NINEPOINT MEDICAL, INC.
- NvisionVLE Imaging Probe 17mm — NINEPOINT MEDICAL, INC.
- NvisionVLE Imaging Probe 17mm Clinical — NINEPOINT MEDICAL, INC.
- NvisionVLE Imaging Probe 20mm — NINEPOINT MEDICAL, INC.
- NvisionVLE Imaging Probe 20mm Clinical — NINEPOINT MEDICAL, INC.
- NvisionVLE Inflation Kit — NINEPOINT MEDICAL, INC.
- NvisionVLE Low Profile Imaging Probe, 0mm Working Distance — NINEPOINT MEDICAL, INC.
- NvisionVLE Low Profile Imaging Probe, 14mm Working Distance — NINEPOINT MEDICAL, INC.
- NvisionVLE Low Profile Imaging Probe, 20mm Working Distance — NINEPOINT MEDICAL, 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
- Ninepoint Medical, Inc.
Sources (1)
- FDA UDI da6df631-0c0f-403b-9a3a-8f13d9be7f72 36 fields · synced May 31, 2026