FDA.reportPublic FDA data

MEDIVISION

Primary DI
00851328007215
Brand
MEDIVISION
Company
MEDIVISION, INC.
Model
MV430
Catalog number
MV430
Device description
CYSTOSCOPEMediVision Cystoscope is for examine of the lower urinary tract, and using additional accessories, to perform various diagnostic and therapeutic procedures.HYSTEROSCOPEMediVision Hysteroscopes are used as tools for access to the uterine cavity and are not, in and of themselves, a method for surgery.
Published
2016-12-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FAJCystoscope And Accessories, Flexible/Rigid
HIHHysteroscope (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAJCystoscope And Accessories, Flexible/RigidGastroenterology, Urology2
HIHHysteroscope (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851328007215PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851328007215008513280072158513280072150851328007215

GMDN Terms#

Term, Definition table
TermDefinition
Rigid optical hysteroscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the canal of the cervix and the uterine cavity (uterus). It is inserted through the vagina during hysteroscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. Distention of the uterus with, e.g., carbon dioxide(CO2) gas may be used to improve viewing. This device is commonly used to evaluate/treat fibroids (myomas), polyps, or causes of severe cramping (dysmenorrhea), heavy menstrual periods (menorrhagia), and bleeding between periods (metrorrhagia). This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Hydrogen Peroxide"", ""Moist Heat or Steam Sterilization"", ""Ethylene Oxide""]"
Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide

Regulatory Flags#

DUNS number
942192550
Device count
1
Premarket exempt
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851328007000MEDIVISIIONMVA2702MVA27022016-12-14
00851328007017MEDIVISIONMVA2701MVA27012016-12-14
00851328007024MEDIVISIONMVA2731MVA27312016-12-14
00851328007031MEDIVISIONMVA2732MVA27322016-12-14
00851328007048MEDIVISIONMVA400SMVA400S2016-12-14
00851328007055MEDIVISIONMVA430SMVA430S2016-12-14
00851328007062MEDIVISIONMVA470SMVA470S2016-12-14
00851328007079MediVisionMVA400MVA4002016-12-14
00851328007086MediVisionMVA430MVA4302016-12-07
00851328007093MediVisionMVA445MVA4452016-12-14
00851328007109MEDIVISIONMVA470MVA4702016-12-14
00851328007178MEDIVISIONMV2900MV29002016-12-14
00851328007185MEDIVISIONMV2930MV29302016-12-14
00851328007192MEDIVISIONMV400MV4002016-12-14
00851328007208MEDIVISIONMV412MV4122016-12-14
00851328007222MEDIVISIONMV470MV4702016-12-14
00851328007239PureDefense Surgical MaskVQN0185WVQN0185W2020-05-12
00851328007246PureDefense Surgical MaskVQN0185BVQN0185B2020-05-12
00851328007116MEDIVISIONMV5500MV55002016-12-14
00851328007123MEDIVISIONMV5530MV55302016-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826926952PENTAX MedicalPENTAX MEDICAL CORPORATIONFAJ2026-08-25
06975339621506BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621513BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621520BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621537BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621926BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621933BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621964BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621971BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
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