Lesinski / Flex H/A®

GUDID 00763000034481

PROSTHESIS 0530 LESINSKI FLEX H/A TOTAL

MEDTRONIC XOMED, INC.

Ossicular prosthesis, total

• Primary Device ID: 00763000034481
• NIH Device Record Key: c24771ef-15db-4d81-bf7a-eea7bda3cbca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lesinski / Flex H/A®
• Version Model Number: 0530
• 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: 8 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000034481 [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 [Lesinski / Flex H/A®]

• 00763000034498: PROSTHESIS 0531 LESINSKI FLEX H/A PART
• 00763000034481: PROSTHESIS 0530 LESINSKI FLEX H/A TOTAL