AccessGUDID - DEVICE: Uro-N Cystoscope (00860008483720)

GUDID

Device Identifier (DI) Information

Brand Name: Uro-N Cystoscope
Version or Model: 1115
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1115
Company Name: UROVIU CORP.

Primary DI Number: 00860008483720
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118239699 *Terms of Use

Device Description: The Uro-N cystoscope system consists of a mulit-use handle with an LCD screeen and a single-use sterile cannula. The Uro-N is intended fr directed injection of therapeutic agents and solutions into target areas of the bladder and the lower urinary tract via a cystoscope.

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?
17145	Rigid optical cystoscope	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the bladder and the urinary tract. 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 cystoscopy. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. It is used to examine/diagnose incontinence, the inability to pass urine (retention), recurrent urinary tract infections, to remove tissue samples/stones/small tumours from the bladder, and for removal of the prostate. This is a reusable device.	Active	false

FDA Product Code

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Product Code	Product Code Name
FAJ	Cystoscope And Accessories, Flexible/Rigid
FBK	Endoscopic Injection Needle, Gastroenterology-Urology

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K182876	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
Length: 269 Millimeter

Device Record Status

Public Device Record Key: d85aa789-55ae-49b2-9f98-0e4dfd734ded
Public Version Date: November 17, 2023
Public Version Number: 2
DI Record Publish Date: December 16, 2022