FDA.reportPublic FDA data

MEDIVISION

Primary DI
00851328007192
Brand
MEDIVISION
Company
MEDIVISION, INC.
Model
MV400
Catalog number
MV400
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
00851328007192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851328007192008513280071928513280071920851328007192

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
00851328007208MEDIVISIONMV412MV4122016-12-14
00851328007215MEDIVISIONMV430MV4302016-12-14
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
07613327055306NASTRYKER CORPORATIONFAJ2016-09-23
07613327055313NASTRYKER CORPORATIONHIH2016-09-23
07613327055313NASTRYKER CORPORATIONFAJ2016-09-23
07613327055320NASTRYKER CORPORATIONFAJ2016-09-23
07613327055337NASTRYKER CORPORATIONFAJ2016-09-23
07613327055344NASTRYKER CORPORATIONFAJ2016-09-23
07613327055351NASTRYKER CORPORATIONFAJ2016-09-23
07613327055368NASTRYKER CORPORATIONFAJ2016-09-23
07613327055375NASTRYKER CORPORATIONFAJ2016-09-23
07613327055382NASTRYKER CORPORATIONFAJ2016-09-23
07613327055399NASTRYKER CORPORATIONHIH2016-09-23
07613327055399NASTRYKER CORPORATIONFAJ2016-09-23
07613327055405NASTRYKER CORPORATIONFAJ2016-09-23
07613327055405NASTRYKER CORPORATIONHIH2016-09-23
07613327055412NASTRYKER CORPORATIONFAJ2016-09-23
07613327055429NASTRYKER CORPORATIONFAJ2016-09-23
07613327055436NASTRYKER CORPORATIONFAJ2016-09-23
07613327055443NASTRYKER CORPORATIONFAJ2016-09-23
07613327055450NASTRYKER CORPORATIONFAJ2016-09-23
07613327055467NASTRYKER CORPORATIONFAJ2016-09-23
07613327055474NASTRYKER CORPORATIONFAJ2016-09-23
07613327055481NASTRYKER CORPORATIONFAJ2016-09-23
07613327055498NASTRYKER CORPORATIONHIH2016-09-23
07613327055498NASTRYKER CORPORATIONFAJ2016-09-23
07613327055504NASTRYKER CORPORATIONFAJ2016-09-23
07613327055511NASTRYKER CORPORATIONFAJ2016-09-23
07613327055528NASTRYKER CORPORATIONFAJ2016-09-23
07613327055535NASTRYKER CORPORATIONFAJ2016-09-23
07613327055542Rev360STRYKER CORPORATIONFAJ2016-09-23
07613327055542Rev360STRYKER CORPORATIONHIH2016-09-23