AccessGUDID - DEVICE: CYSTO-NEPHRO VIDEOSCOPE (04953170411250)

GUDID

Device Identifier (DI) Information

Brand Name: CYSTO-NEPHRO VIDEOSCOPE
Version or Model: OLYMPUS CYF-VH
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N6006040
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170411250
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 711789789 *Terms of Use

Device Description: CYSTO-NEPHRO VIDEOSCOPE

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):	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?
46723	Flexible video cystonephroscope, reusable	An endoscope with a flexible inserted portion intended for the visual examination/treatment of the bladder, urethra (including prostate region), and kidneys. It is inserted into the urethra via the natural urinary orifice, or percutaneously into the renal pelvis for the kidneys during endoscopy. Anatomical images are obtained via a camera incorporated at its distal end and are shown on a monitor. It is typically used for the removal/crushing of stones, investigation of pyelitis and renal failure, treatment of lesions of the urinary bladder/posterior urethra, or to evaluate bladder control/incontinence. 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 [?]
K221683	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
High-level Disinfectant
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 53d516c4-dad9-4f9e-88d0-8f11121592ec
Public Version Date: June 19, 2024
Public Version Number: 6
DI Record Publish Date: July 29, 2019