AccessGUDID - DEVICE: BOA VISION (00814334022825)

GUDID

Device Identifier (DI) Information

Brand Name: BOA VISION
Version or Model: 7355071US
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7355071US
Company Name: Richard Wolf GmbH

Primary DI Number: 00814334022825
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: SENSOR-URETERORENOSCOPE 8.7FR WL 680MM flexible, working channel 3.6Fr, slanted distal tip Ø 6.6Fr, TL 980mm, deflection +270°/-270°, two function buttons, for connection to ENDOCAM Logic HD, LED-illumination, distal Sensor, Fixfocus

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?
38703	Flexible video ureterorenoscope, reusable	An endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter and renal pelvis. It is inserted through the external urethral orifice or a surgically-created percutaneous route during a urological procedure. Anatomical images are transmitted to the user by a video system with an electronic image sensor at the distal end of the endoscope and the images showing on a monitor. This device is commonly used for the removal or crushing of stones, and evaluation of pyelitis and renal failure. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FGA	Kit, nephroscope
FGB	Ureteroscope 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: 2.9 Millimeter
Length: 680 Millimeter

Device Record Status

Public Device Record Key: 314e56e3-4896-484a-af89-e14ccfe285b8
Public Version Date: November 21, 2024
Public Version Number: 3
DI Record Publish Date: July 15, 2021