Austin

GUDID 00681490035477

PROSTHESIS 1156305 AUSTIN TOTAL 3MM HD

MEDTRONIC XOMED, INC.

Ossicular prosthesis, total Ossicular prosthesis, total

• Primary Device ID: 00681490035477
• NIH Device Record Key: f30668ba-9598-46d7-b314-e8de89ce05a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Austin
• Version Model Number: 1156305
• Company DUNS: 835465063
• Company Name: MEDTRONIC XOMED, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00681490035477 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K823441

FDA Product Code

• LBM: POROUS POLYETHYLENE OSSICULAR REPLACEMENT

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: 2015-06-22

On-Brand Devices [Austin]

• 00681490035897: SHUNT 1156505 AUSTIN ENDOLYMPHATIC
• 00681490035798: SHUNT 1156404 AUSTIN ENDOLYMPHATIC
• 00681490035712: PROSTHESIS 1156361 AUSTIN OFFSET PARTIAL
• 00681490035477: PROSTHESIS 1156305 AUSTIN TOTAL 3MM HD