Flexible Video Cystoscope (NTSC) Intuitive 08-5203

GUDID 00874485001278

Intuitive

COGENTIX MEDICAL, INC.

Flexible video cystoscope, reusable

• Primary Device ID: 00874485001278
• NIH Device Record Key: eb8386af-a2f4-4664-b894-8ac1c8235bb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flexible Video Cystoscope (NTSC) Intuitive
• Version Model Number: CST-5000i
• Catalog Number: 08-5203
• 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: true
• 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	00874485001278 [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

[00874485001278]

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: 2016-09-22

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

• 00874485002978: Intuitive
• 00874485001278: Intuitive