Flexible Fiber Laryngoscope, Standard Set 02-4202

GUDID 00874485001360

COGENTIX MEDICAL, INC.

Flexible fibreoptic nasopharyngoscope

• Primary Device ID: 00874485001360
• NIH Device Record Key: 92b1ee98-78fd-4369-ac87-c0d5be0e7266
• Commercial Distribution Discontinuation: 2018-07-26
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Flexible Fiber Laryngoscope, Standard Set
• Version Model Number: ENT-4000
• Catalog Number: 02-4202
• 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@cogntixmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00874485001360 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050972

FDA Product Code

• EOB: Nasopharyngoscope (Flexible Or Rigid)

Sterilization

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

[00874485001360]

High-level Disinfectant

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-07-02
• Device Publish Date: 2016-09-22

On-Brand Devices [Flexible Fiber Laryngoscope, Standard Set]

• 00874485001629: ENT-4500
• 00874485001360: ENT-4000