Vincent

GUDID 00763000036829

PROSTHESIS 1160050 TI PART VINCENT HA

MEDTRONIC XOMED, INC.

Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial

• Primary Device ID: 00763000036829
• NIH Device Record Key: cfe474f2-ab50-4b1d-ac51-76cdc76432cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vincent
• Version Model Number: 1160050
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Length: 2 Millimeter
• Length: 2 Millimeter
• Length: 2 Millimeter
• Length: 2 Millimeter
• Length: 2 Millimeter
• Length: 2 Millimeter
• Length: 2 Millimeter
• Length: 2 Millimeter
• Length: 2 Millimeter
• Length: 2 Millimeter
• Length: 2 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000036829 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002897

FDA Product Code

• ETB: PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-15
• Device Publish Date: 2021-11-07

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• 00763000882396 - NIM: 2024-02-12 EMG TUBE 8229307 NIM STD 7MM ROHS
• 00763000882402 - NIM: 2024-02-12 EMG TUBE 8229308 NIM STD 8MM ROHS
• 00763000882419 - NIM: 2024-02-12 EMG TUBE 8229506 NIM CONT 6MM ROHS
• 00763000882426 - NIM: 2024-02-12 EMG TUBE 8229507 NIM CONT 7MM ROHS
• 00763000882433 - NIM: 2024-02-12 EMG TUBE 8229508 NIM CONT 8MM ROHS