EndoSheath Technology 03-5101

GUDID 20874485002996

EndoSheath Technology for the TNE-5000 Video Esophagoscope

COGENTIX MEDICAL, INC.

Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover 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