AIRVANCE®

GUDID 00763000089757

BONE SCREW 76353200M AIRVANCE SYSTEM

MEDTRONIC XOMED, INC.

Sleep apnoea tongue implant, non-bioabsorbable Sleep apnoea tongue implant, non-bioabsorbable

• Primary Device ID: 00763000089757
• NIH Device Record Key: 59252ba9-37b5-45d3-af9c-49247c711193
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AIRVANCE®
• Version Model Number: 76353200M
• Company DUNS: 835465063
• Company Name: MEDTRONIC XOMED, 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000089757 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122391

FDA Product Code

• LRK: Device, anti-snoring

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-13

On-Brand Devices [AIRVANCE®]

• 00643169523272: BONE SCREW 76310200M AIRVANCE
• 00643169523265: BONE SCREW 76353200M AIRVANCE SYS ROHS
• 00763000089757: BONE SCREW 76353200M AIRVANCE SYSTEM