AccessGUDID - DEVICE: OES CYSTONEPHROFIBERSCOPE (04953170411144)

GUDID

Device Identifier (DI) Information

Brand Name: OES CYSTONEPHROFIBERSCOPE
Version or Model: OLYMPUS CYF-5
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170411144
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 711789789 *Terms of Use

Device Description: OES CYSTONEPHROFIBERSCOPE

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?
46722	Flexible fibreoptic cystonephroscope	An endoscope with a flexible inserted portion intended for the visual examination/treatment of the bladder, the urethra (including the prostate region), and the kidneys. It is inserted into the urethra through the natural urinary orifice, and percutaneously into the renal pelvis for the kidneys during an endoscopic procedure. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used for the removal/crushing of stones, pyelitis, and renal failure (nephroscopy); and treatment of lesions of the urinary bladder/posterior urethra, or to evaluate bladder control/incontinence (cystoscopy). 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 [?]
K221690	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Ethylene Oxide
High-level Disinfectant

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: dadba846-4c6d-4e37-be63-f3768b54a7b3
Public Version Date: April 22, 2024
Public Version Number: 4
DI Record Publish Date: July 29, 2019