AccessGUDID - DEVICE: FIBER CYTOSCOPE (04961333232734)

GUDID

Device Identifier (DI) Information

Brand Name: FIBER CYTOSCOPE
Version or Model: FCY-15P2
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: PENTAX OF AMERICA, INC.

Primary DI Number: 04961333232734
Issuing Agency: GS1
Commercial Distribution End Date: April 06, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 083211284 *Terms of Use

Device Description: FIBER OPTIC CYSTOSCOPE 2.2C 4.8TP 400L (REFURBISHED)

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?
35980	Flexible fibreoptic cystoscope	An endoscope with a flexible 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 by the device through a fibreoptic bundle. This device is commonly used to examine/diagnose incontinence, the inability to pass urine (retention), recurrent urinary tract infections, and to remove tissue samples/stones/small tumours from the bladder. 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 [?]
K914008	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: 9b7fbbf4-2d5c-404b-8f0e-37661f6b4e05
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: April 06, 2017