FDA.report

NA

Primary DI
04055207013717
Brand
NA
Company
Richard Wolf GmbH
Model
7325122
Catalog number
7325.122
Device description
FIBER-HYSTEROSCOPE Ø 2.5MM WL 200MM flexible, working channel Ø 1.2mm, TL 450mm, deflection +130°/-130°, glass fiber light cable, fiber image carrier
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HIHHYSTEROSCOPE (AND ACCESSORIES)
HRXArthroscope

Product Code Classifications

CodeDeviceSpecialtyClass
HIHHysteroscope (And Accessories)Obstetrics/Gynecology2
HRXArthroscopeOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207013717PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207013717040552070137174055207013717

GMDN Terms

TermDefinition
Flexible fibreoptic hysteroscopeAn endoscope with a flexible 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 a fibreoptic bundle. Distention of the uterus with either liquid or 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.

Device Sizes

TypeValueUnit
Length200Millimeter
Outer Diameter2.5Millimeter

Sterilization Methods

Method
Ethylene Oxide;Hydrogen Peroxide
Hydrogen Peroxide

Contacts

PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags

DUNS number
315304071
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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