Vincent Flex H/A®

GUDID 00763000036430

PROSTHESIS 1150050 UNIV TITAN VINCENT HD

MEDTRONIC XOMED, INC.

Ossicular prosthesis, total

• Primary Device ID: 00763000036430
• NIH Device Record Key: f6694211-77bf-46a9-aadc-bd919ee49660
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vincent Flex H/A®
• Version Model Number: 1150050
• 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

• Device Size Text, specify: 0
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000036430 [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

Devices Manufactured by MEDTRONIC XOMED, INC.

• 00199150023851 - N/A: 2026-02-24 PROBE 8225101E PRASS STD PROT HANDLE
• 00199150023868 - N/A: 2026-02-24 PROBE 8225101 5PK PRASS STD PROT HANDLE
• 00199150023875 - N/A: 2026-02-24 PROBE 8225110 10PK PRASS STD
• 00199150023882 - N/A: 2026-02-24 PROBE 8225103 5PK PRASS SLIM PROT HANDLE
• 00763000548797 - Hydrodebrider: 2026-02-23 HYDRODEBRIDER 1914001 STD HANDPIECE ROHS
• 00763000548803 - Hydrodebrider: 2026-02-23 HANDPIECE 1921002 HYDRODEBRID FRNTL ROHS
• 20763000888910 - Merocel: 2026-02-23 PACKING 400151 100PK MICRO SPHERES 4MM
• 20763000888927 - Merocel: 2026-02-23 PACKING 400152 100PK MICRO SPHERES 5MM