Flex H/A®

GUDID 00763000036195

PROSTHESIS 1150000 UNIV TITAN RND HEAD

MEDTRONIC XOMED, INC.

Ossicular prosthesis, total

• Primary Device ID: 00763000036195
• NIH Device Record Key: 4d631b14-a925-43ae-9f34-48c3fb60b1b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flex H/A®
• Version Model Number: 1150000
• 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	00763000036195 [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

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