Flexible Fiberoptic Cystoscope

Basic Information

• Brand Name: Flexible Fiberoptic Cystoscope
• Primary DI: 00874485001599
• Version / Model: CST-4000
• Catalog Number: 08-4201
• Company Name: COGENTIX MEDICAL, INC.
• Labeler DUNS: 780024725
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: f576162a-1a8b-4aef-b00b-afe6196d4636

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: High-level Disinfectant

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	884.1690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00874485001599	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]