FDA.report

NA

Primary DI
04055207013663
Brand
NA
Company
Richard Wolf GmbH
Model
7305006
Catalog number
7305.006
Device description
FIBER-CYSTOSCOPE 15FR WL 400MM flexible, working channel 7.5Fr, slanted distal tip, TL 660mm, deflection +210°/-150°, glass fiber light cable, fiber
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
FAJCystoscope and accessories, flexible/rigid
FBOCYSTOURETHROSCOPE

Product Code Classifications

CodeDeviceSpecialtyClass
FAJCystoscope And Accessories, Flexible/RigidGastroenterology, Urology2
FBOCystourethroscopeGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207013663PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207013663040552070136634055207013663

GMDN Terms

TermDefinition
Flexible fibreoptic cystourethroscopeAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the bladder and the urethra, including the prostate region. It is inserted into the urethra (the tube that carries urine from the bladder to the outside of the body) through the natural urinary orifice during an endourologic procedure. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used for biopsy, removal of concretions (small stones), treatment of lesions of the urinary bladder/posterior urethra, or to evaluate bladder control/incontinence. This is a reusable device.

Device Sizes

TypeValueUnit
Length400Millimeter
Outer Diameter5Millimeter

Sterilization Methods

Method
Hydrogen Peroxide
Hydrogen Peroxide;Ethylene Oxide

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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