Invotec Nasal Septal Button 20-10400S

GUDID 00818501020010

A device that is implanted to occlude a perforation in the nasal septum. It typically consists of a central post and two flanged ends. The device is inserted into a nostril, one leaf is folded and placed through the septum perforation, grasped through the opposite nostril and secured closing the perforation. It is used to improve nasal respiration.

INVOTEC INTERNATIONAL, INC.

Nasal septal button Nasal septal button

• Primary Device ID: 00818501020010
• NIH Device Record Key: 053f02f1-7cce-4002-a30a-2706e911b198
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Invotec Nasal Septal Button
• Version Model Number: 001
• Catalog Number: 20-10400S
• Company DUNS: 622812592
• Company Name: INVOTEC INTERNATIONAL, 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818501020010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K901366

FDA Product Code

• LFB: Button, Nasal Septal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-03

On-Brand Devices [Invotec Nasal Septal Button]

• 00818501020010: A device that is implanted to occlude a perforation in the nasal septum. It typically consists o
• 00818501020003: A device that is implanted to occlude a perforation in the nasal septum. It typically consists o