Medivision

FDA UDI

Class II (US FDA UDI)

by Medivision, Inc.

Identity

Trade Name: MEDIVISION FDA UDI
Generic Name: Rigid optical hysteroscope FDA UDI
Device Name: CYSTOSCOPE MediVision Cystoscope is for examine of the lower urinary tract, and using additional accessories, to perform various diagnostic and therapeutic procedures. HYSTEROSCOPE MediVision Hysteroscopes are used as tools for access to the uterine cavity and are not, in and of themselves, a method for surgery. FDA UDI
Model / Reference: MV470 FDA UDI
Description: CYSTOSCOPE MediVision Cystoscope is for examine of the lower urinary tract, and using additional accessories, to perform various diagnostic and therapeutic procedures. HYSTEROSCOPE MediVision Hysteroscopes are used as tools for access to the uterine cavity and are not, in and of themselves, a method for surgery. FDA UDI

Identifiers

Catalog Number: MV470 FDA UDI
Primary DI / UDI-DI: 00851328007222 FDA UDI
FDA Product Code: HIH FDA UDI
FAJ FDA UDI
GMDN Term: Rigid optical hysteroscope FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.1690 FDA UDI
876.1500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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Single Use

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Implantable

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Contains Latex

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Prescription Use

Yes

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Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

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Lot / Batch Number

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Serial Number

Yes

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Expiration Date

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Manufacturing Date

FDA UDI

Category: Rigid optical cystoscope Rigid optical hysteroscope

Medivision by Medivision, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rigid optical hysteroscope.

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BR Surgical, LLC — BR SURGICAL LLC · Class II
TRUCLEAR — Smith & Nephew, Inc. · Class II
MyoSure XL Rod Lens Hysteroscope — Hologic, Inc. · Class II
Hysteroscope — SOPRO-COMEG GmbH · Class II
HOPKINS — Karl Storz GmbH & Co. KG · Class II
Gimmi — Gimmi GmbH · Class II
HOPKINS — Karl Storz GmbH & Co. KG · 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

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Manufacturer

Manufacturer: Medivision, Inc.

Sources (1)

FDA UDI 0336c3ba-f5df-4324-a0d9-ff94672d5316 34 fields · synced May 31, 2026