FDA.reportPublic FDA data

NA

Primary DI
04055207045039
Brand
NA
Company
Richard Wolf GmbH
Model
8982035
Catalog number
8982.035
Device description
VAGINOSCOPE-TUBE ID 9.1MM OD 11.5MM for adults, TL 107mm, distal end straight, reusable
Published
2016-09-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MOKVAGINOSCOPE AND ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOKVaginoscope And AccessoriesObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207045039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207045039040552070450394055207045039

GMDN Terms#

Term, Definition table
TermDefinition
VaginoscopeA hand-held endoscope intended to be used for the examination of the vagina, usually in children, typically when searching for foreign bodies or sources of bleeding. It comprises an optical vaginal speculum, cold-light lighting, and a magnification device. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter9.1Millimeter
Outer Diameter11.5Millimeter

Sterilization Methods#

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

Contacts#

Phone, Email table
PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags#

DUNS number
315304071
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04055207056585HIGHFLOW223560122356012017-07-21
04055207056592HIGHFLOW223561122356112017-07-21
04055207026526ERAGON BIPOLAR83930031839300312016-09-27
04055207026533ERAGON BIPOLAR83930032839300322016-09-27
04055207026540ERAGON BIPOLAR83930033839300332016-09-27
04055207026557ERAGON BIPOLAR83930034839300342016-09-27
04055207026564ERAGON BIPOLAR83930035839300352016-09-23
04055207026588ERAGON BIPOLAR83930041839300412016-09-27
04055207026724ERAGON BIPOLAR83930921839309212016-09-27
04055207033876ERAGON BIPOLAR8393001028393001022016-09-27
04055207055540ERAGON BIPOLAR83930037839300372016-09-27
04055207066805NA880888.082026-06-02
04055207007709NA180118.012026-05-29
04055207007723RIWO880388.032026-05-29
04055207007747NA890089.002026-05-29
04055207007792NA890589.052026-05-29
04055207007815NA890989.092026-05-29
04055207007839NA892089.202026-05-29
04055207008409NA8917189.1712026-05-29
04055207038505RIWO880088.002026-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10607915145344GelPOINT V-PathAPPLIED MEDICAL RESOURCES CORPORATIONMOK2023-03-17
10607915145351GelPOINT V-Path APPLIED MEDICAL RESOURCES CORPORATIONMOK2023-03-17
10607915145368GelPOINT V-PathAPPLIED MEDICAL RESOURCES CORPORATIONMOK2023-03-17
04055207044995NARichard Wolf GmbHMOK2016-09-28
04055207045008NARichard Wolf GmbHMOK2016-09-28
04055207045015NARichard Wolf GmbHMOK2016-09-28
04055207045022NARichard Wolf GmbHMOK2016-09-28
04055207045046NARichard Wolf GmbHMOK2016-09-28
04048551405499n.a.Karl Storz GmbH & Co. KGMOK2016-09-23