Flexible Video Cystoscope (NTSC) 08-5205

GUDID 00874485002961

COGENTIX MEDICAL, INC.

Flexible video cystoscope, reusable

• Primary Device ID: 00874485002961
• NIH Device Record Key: 688d03e1-9824-4f27-a95a-6eed886dd214
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flexible Video Cystoscope (NTSC)
• Version Model Number: CST-5000S
• Catalog Number: 08-5205
• Company DUNS: 780024725
• Company Name: COGENTIX MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 866-258-2182
• Email: customercare@cogentixmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00874485002961 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072180

FDA Product Code

• FAJ: Cystoscope And Accessories, Flexible/Rigid

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00874485002961]

High-level Disinfectant

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [Flexible Video Cystoscope (NTSC)]

• 00874485002961: CST-5000S
• 00874485000882: CST-5000