AccessGUDID - DEVICE: VIPER (04055207013700)

GUDID

Device Identifier (DI) Information

Brand Name: VIPER
Version or Model: 7325076
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7325.076
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207013700
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: FIBER-URETERORENOSCOPE 9.6FR WL 680MM flexible, working channel 3.6Fr, slanted distal tip Ø 6 Fr, TL 1005mm, deflection +270°/-270°, 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?
37111	Flexible fibreoptic ureterorenoscope	An endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter and the renal pelvis. It is inserted through the external urethral orifice during a urological procedure. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used for the removal or crushing of stones, pyelitis, and renal failure. 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
Length: 680 Millimeter
Outer Diameter: 3.2 Millimeter

Device Record Status

Public Device Record Key: 5dc3288e-89b5-4f5e-aea7-52acd26b975d
Public Version Date: April 26, 2021
Public Version Number: 3
DI Record Publish Date: September 23, 2016