AccessGUDID - DEVICE: NA (04055207013663)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 7305006
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7305.006
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207013663
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

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 image carrier, manual focus

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36632	Flexible fibreoptic cystourethroscope	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FAJ	Cystoscope and accessories, flexible/rigid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Hydrogen Peroxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 5 Millimeter
Length: 400 Millimeter

Device Record Status

Public Device Record Key: 2689aa90-accd-43ff-ab82-4176bb2d7d08
Public Version Date: April 26, 2021
Public Version Number: 3
DI Record Publish Date: September 23, 2016