AccessGUDID - DEVICE: RIWO D-URS (04055207064177)

GUDID

Device Identifier (DI) Information

Brand Name: RIWO D-URS
Version or Model: 473572076
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 473572076
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207064177
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: SENSOR-URETERORENOSCOPE 9FR WL 600MM flexible, working channel 1: 3,6FR, working channel 2: 1,65FR, PU= 3 pcs, sterile, for single use

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:	Yes
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?
63516	Rigid video ureterorenoscope	An endoscope with a rigid or semi-rigid inserted portion intended for the visual examination and treatment of the ureter and the renal pelvis; some types may have a flexible tip at the distal end of the inserted portion. It is inserted through the external urethral orifice during a urological procedure whereby anatomical images are transmitted by a video system via an image sensor chip at the distal end of the endoscope and displayed on a monitor. This device is typically used for the removal or crushing of stones, and evaluation of pyelitis and renal failure. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FGB	Ureteroscope and accessories, flexible/rigid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K201897	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 5 and 30 Degrees Celsius
Storage Environment Humidity: between 10 and 70 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Length: 600 Millimeter
Outer Diameter: 3 Millimeter

Device Record Status

Public Device Record Key: 8292d003-822f-4b30-9dc2-5472364b52f2
Public Version Date: November 21, 2024
Public Version Number: 4
DI Record Publish Date: May 17, 2021