Identity
- Trade Name
- VersaVue Video Box FDA UDI
- Generic Name
- Flexible video cystoscope, single-use FDA UDI
- Device Name
- VersaVue Video Box The VersaVue™ Tablet and VersaVue™ Video Box are plug-and-play visualization modules that are used with disposable VersaVue™ Cystoscopes to project images onto a monitor. FDA UDI
- Model / Reference
- 5018 FDA UDI
- Description
- VersaVue Video Box The VersaVue™ Tablet and VersaVue™ Video Box are plug-and-play visualization modules that are used with disposable VersaVue™ Cystoscopes to project images onto a monitor. FDA UDI
Identifiers
- Catalog Number
- M0067806999 FDA UDI
- Primary DI / UDI-DI
- 04719872710196 FDA UDI
- FDA Product Code
- FAJ FDA UDI
- GMDN Term
- Flexible video cystoscope, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
Yes
FDA UDI
Category: Flexible video cystoscope, single-use
VersaVue Video Box by Medimaging Integrated Solution Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Flexible video cystoscope, single-use.
- Single-Use Flexible Cystoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
- Single-Use Flexible Cystoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
- Single-Use Flexible Cystoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
- Single-Use Flexible Cystoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
- Prosurg — Prosurg, Inc · Class II
- Aptra — OTU MEDICAL INC. · Class II
- Prosurg — Prosurg, Inc · Class II
- Uro-G Flexible Cystoscope — UroViu Corporation · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medimaging Integrated Solution Inc.
Sources (2)
- FDA UDI f70f1603-843f-4e54-8951-d771572a5574 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026