EndoSheath Technology 03-5101

GUDID 20874485002996

EndoSheath Technology for the TNE-5000 Video Esophagoscope

COGENTIX MEDICAL, INC.

Optical medical device procedural cover

• Primary Device ID: 20874485002996
• NIH Device Record Key: ce365a08-efdd-4365-b903-5144324ba7d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EndoSheath Technology
• Version Model Number: TV-2.1
• Catalog Number: 03-5101
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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
• Phone: 866-258-2182
• Email: customercare@cogentixmedical.com
• Phone: 866-258-2182
• Email: customercare@cogentixmedical.com
• Phone: 866-258-2182
• Email: customercare@cogentixmedical.com
• Phone: 866-258-2182
• Email: customercare@cogentixmedical.com
• Phone: 866-258-2182
• Email: customercare@cogentixmedical.com
• Phone: 866-258-2182
• Email: customercare@cogentixmedical.com
• Phone: 866-258-2182
• Email: customercare@cogentixmedical.com
• Phone: 866-258-2182
• Email: customercare@cogentixmedical.com
• Phone: 866-258-2182
• Email: customercare@cogentixmedical.com
• Phone: 866-258-2182
• Email: customercare@cogentixmedical.com
• Phone: 866-258-2182
• Email: customercare@cogentixmedical.com
• Phone: 866-258-2182
• Email: customercare@cogentixmedical.com
• Phone: 866-258-2182
• Email: customercare@cogentixmedical.com
• Phone: 866-258-2182
• Email: customercare@cogentixmedical.com
• Phone: 866-258-2182
• Email: customercare@cogentixmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00874485002985 [Primary]
GS1	20874485002996 [Package]; Contains: 00874485002985; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072088

FDA Product Code

• EOX: Esophagoscope (Flexible Or Rigid)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-21
• Device Publish Date: 2016-09-23

On-Brand Devices [EndoSheath Technology]

• 00874485003173: EndoSheath Technology for the CST-5000 Cystoscope
• 00874485003166: EndoSheath Technology for CST-5000 Cystoscope
• 00874485003159: EndoSheath Technology for CST-4000 Cystoscope
• 00874485003142: EndoSheath Technology for CST-4000 Cystoscope
• 00874485003135: EndoSheath Technology for BRS-5100 Video Bronchoscope
• 00874485003128: EndoSheath Technology for BRS-5100 Video Bronchoscope
• 00874485003111: EndoSheath Technology for BRS-5100 Video Bronchoscope
• 00874485003104: EndoSheath Technology for BRS-5100 Video Bronchoscope
• 00874485003098: EndoSheath Technology for BRS-5000 Video Bronchoscope
• 00874485003074: EndoSheath Technology for BRS-5000 Video Bronchoscope
• 00874485003067: EndoSheath Technology for BRS-5000 Video Bronchoscope
• 00874485003050: EndoSheath Technology for BRS-4000 Fiber Bronchoscope
• 00874485003043: EndoSheath Technology for BRS-4000 Fiber Bronchoscope
• 00874485003036: EndoSheath Technology for BRS-4000 Fiber Bronchoscope
• 00874485003029: EndoSheath Technology for BRS-4000 Fiber Bronchoscope
• 20874485003016: EndoSheath Technology for the TNE-5000 Video Esophagoscope
• 20874485002996: EndoSheath Technology for the TNE-5000 Video Esophagoscope