FDA.reportPublic FDA data

VersaVue™

Primary DI
04719872715184
Brand
VersaVue™
Company
MEDIMAGING INTEGRATED SOLUTION INC.
Model
5008
Catalog number
M0067801522
Device description
VersaVue – Reverse Deflection Demo Scope Single The VersaVue™ Single-Use Flexible Cystoscope is a sterile, single-use, and flexible device intended to be operated with its compatible display system. The device provides endoscopic visualization to aid in diagnosis and treatment within the lower urinary tract. The Cystoscope is intended to provide visualization via displaying unit. The Cystoscope is intended for use in a hospital environment. It is designed for use in adults.
Published
2023-10-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FAJCystoscope And Accessories, Flexible/Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAJCystoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719872715184PackageGS14In Commercial Distribution
04719872715191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719872715184047198727151844719872715184
04719872715191047198727151914719872715191

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video cystoscope, single-useA sterile endoscope with a flexible inserted portion intended for the visual examination and treatment of the bladder and the urinary tract by introduction through the urethra. Anatomical images are transmitted from a distal camera and displayed on a monitor. It is typically used to examine/diagnose incontinence, urinary retention, recurrent urinary tract infections, and/or to remove tissue specimens/stones/small tumours from the bladder; it may have specialized tools for functions such as ureteral stent removal. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
656813438
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719872710219MiiS Horus scope50382026-04-29
04719872710226MiiS Horus scope50422026-04-29
04719872711230MiiS18022026-04-29
04719872715016MiiS Horus scope50012026-04-29
04719872715023MiiS Horus Video Box50022026-04-29
04719872715108MiiS Horus scope50052026-04-29
04719872715115MiiS Horus scope50062026-04-29
04719872715122MiiS Horus scope50072026-04-29
04719872715283MiiS Horus Endoscope Display System50312026-04-29
04719872715290MiiS Horus Endoscope Display System50332026-04-29
04719872710196VersaVue Video Box5018M00678069992025-07-23
04719872715313VersaVue Tablet - Global/CE5015M00678051002025-04-15
04719872715320VersaVue Tablet - Global/CE Demo5015M0067805100D2025-04-15
04719872715337VersaVue Tablet - Global/CE Repair5015M0067805100R2025-04-15
04719872715344VersaVue Tablet Power Cord – UAE/SA/KW5015M00678050212025-04-15
04719872715351VersaVue Tablet Power Cord – QA/LB/JO5015M00678050312025-04-15
04719872715368VersaVue Tablet Power Cord - Israel5015M00678050122025-04-15
04719872715252 VersaVue™ Power Cord - US/JP/TW5015M00678050102023-10-20
04719872715146 VersaVue™5008M00678010102023-10-20
04719872715153 VersaVue™5008M00678015102023-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850023925442WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925459WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925466WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925473WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925558WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925565WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925572WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925589WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925596WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925909WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925916WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925923WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925930WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925954WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925985WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925992WiScope®Otu Medical Inc.FAJ2026-07-28
06972084140498WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140504WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140511WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140528WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140597WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140603WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140610AptraNingbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140627AptraNingbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140665WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140672WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140689WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140696WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
00848657078450AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-22
00810143893137Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21