AccessGUDID - DEVICE: Uro-G Flexible Cystoscope (00860008483706)

GUDID

Device Identifier (DI) Information

Brand Name: Uro-G Flexible Cystoscope
Version or Model: 1520
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1520
Company Name: UROVIU CORP.

Primary DI Number: 00860008483706
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118239699 *Terms of Use

Device Description: The Uro-G Flexible Cystoscope System consists of a multi-use handle with an LCD screen and a single-use sterile cannula. The Uro-G Flexible Cystoscope is intended for endoscopic diagnosis and infusion of irrigating fluid within the bladder and urethra.

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):	Yes
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?
61728	Flexible video cystoscope, single-use	A sterile endoscope with a flexible inserted portion intended for the visual examination and treatment of the bladder and the urinary tract by introduction through the urethra. Anatomical images are transmitted from a distal camera and displayed on a monitor. It is typically used to examine/diagnose incontinence, urinary retention, recurrent urinary tract infections, and/or to remove tissue specimens/stones/small tumours from the bladder; it may have specialized tools for functions such as ureteral stent removal. This is a single-use 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 [?]
K202921	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 -10 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1910a91f-cc07-46da-9a47-3e3913566011
Public Version Date: December 26, 2022
Public Version Number: 1
DI Record Publish Date: December 16, 2022