Flex H/A®

GUDID 00763000034603

PROSTHESIS 0579 INCUS NECROSIS SMALL

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: 00763000034603
• NIH Device Record Key: 6fd576e4-95e8-4436-86ab-dce9646e0a5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flex H/A®
• Version Model Number: 0579
• 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

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 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 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 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	00763000034603 [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: 2021-11-15
• Device Publish Date: 2021-11-07

On-Brand Devices [Flex H/A®]

• 00763000043155: PROSTHESIS 0580 INCUS NECROSIS MED
• 00763000036201: PROSTHESIS 1150001 UNIV TITAN CAM HEAD
• 00763000036195: PROSTHESIS 1150000 UNIV TITAN RND HEAD
• 00763000034610: PROSTHESIS 0581 INCUS NECROSIS LRG
• 00763000034603: PROSTHESIS 0579 INCUS NECROSIS SMALL
• 00763000034597: PROSTHESIS 0570 FLEX H/A OFFSET 4X5
• 00763000034559: PROSTHESIS 0555 FLEX H/A OFFSET PARTIAL
• 00763000034542: PROSTHESIS 0551 FLEX H/A PARTIAL 3MM
• 00763000034511: PROSTHESIS 0541 FLEX H/A MALLEUS PARTIAL
• 00763000034504: PROSTHESIS 0540 FLEX H/A MALLEUS TOTAL
• 00763000034429: PROSTHESIS 0523 FLEX H/A TOTAL 3MM HD
• 00763000034412: PROSTHESIS 0520 FLEX H/A OFF TOTAL 4MM
• 00763000034399: PROSTHESIS 0510 FLEX H/A OFFSET TOTAL
• 00763000034344: PROSTHESIS 0501 FLEX H/A TOTAL 3MM 7MM L
• 00763000034337: PROSTHESIS 0500 FLEX H/A TOTAL 4MM 7MM L
• 00763000033323: PROSTHESIS 0590 FLEX H/A CONVERTIBLE
• 00763000033316: PROSTHESIS 0550 FLEX H/A PARTIAL 4MM
• 00763000033309: PROSTHESIS 0524 FLEX H/A PARTIAL 3MM HD