NvisionVLE Marking Console with IRIS

FDA UDI

Class II (US FDA UDI)

by Ninepoint Medical, Inc.

Identity

Trade Name: NvisionVLE Marking Console with IRIS FDA UDI
Generic Name: Endoscopic optical coherence tomography system FDA UDI
Model / Reference: 94301-MI FDA UDI

Identifiers

Catalog Number: 94301-MI FDA UDI
Primary DI / UDI-DI: 00859591006249 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Endoscopic optical coherence tomography system

NvisionVLE Marking Console with IRIS by Ninepoint Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic optical coherence tomography system.

NvisionVLE Imaging System with Targeted Biopsy - Upgrade — NINEPOINT MEDICAL, INC. · Class II
NvisionVLE Imaging Console — NINEPOINT MEDICAL, INC. · Class II
NvisionVLE Marking Console with IRIS, Upgraded, Refurbished — NINEPOINT MEDICAL, INC. · Class II
NvisionVLE Imaging Console Refurbished — 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

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: Ninepoint Medical, Inc.

Sources (1)

FDA UDI 59b079ab-e306-4e5e-8005-73133145d070 35 fields · synced May 31, 2026