Flex H/A

GUDID 00763000913519

PROSTHESIS 0523 FLEX H/A TOTAL 3MM HD

MEDTRONIC XOMED, INC.

Ossicular prosthesis, total

• Primary Device ID: 00763000913519
• NIH Device Record Key: d91bb85c-dc9d-4663-80db-d42f64beca6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flex H/A
• Version Model Number: 0523
• Company DUNS: 835465063
• Company Name: MEDTRONIC XOMED, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00763000913519 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K904239

FDA Product Code

• ETA: REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL

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: 2025-07-01
• Device Publish Date: 2025-06-23

On-Brand Devices [Flex H/A]

• 00763000913601: PROSTHESIS 0580 INCUS NECROSIS MED
• 00763000913595: PROSTHESIS 0570 FLEX H/A OFFSET 4X5
• 00763000913564: PROSTHESIS 0541 FLEX H/A MALLEUS PARTIAL
• 00763000913557: PROSTHESIS 0530 LESINSKI FLEX H/A TOTAL
• 00763000913533: PROSTHESIS 0525 CAUSSE FLEX H/A OFF TOTL
• 00763000913526: PROSTHESIS 0524 FLEX H/A PARTIAL 3MM HD
• 00763000913519: PROSTHESIS 0523 FLEX H/A TOTAL 3MM HD