FDA.reportPublic FDA data

VersaVue Tablet - Global/CE

Primary DI
04719872715313
Brand
VersaVue Tablet - Global/CE
Company
MEDIMAGING INTEGRATED SOLUTION INC.
Model
5015
Catalog number
M0067805100
Device description
VersaVue Tablet - Global/CEThe 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.
Published
2025-04-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04719872715313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719872715313047198727153134719872715313

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
Serial number
true
Manufacturing date on label
true

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
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
04719872715177 VersaVue™5008M00678010222023-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848657078450AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-22
00810143893137Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893144Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893151Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893168Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893175Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893182Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893199Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893205Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893212Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893229Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893236Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893243Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893250Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893267Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893274Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893281Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893298Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893304Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893311Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00848657076609AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657076616AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657076623AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657078412AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657078429AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657078436AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657078443AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657085656AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657085663AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00810143893007Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-20