Causse / Flex H/A®

GUDID 00763000034443

PROSTHESIS 0526 CAUSSE FLEX H/A PARTIAL

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: 00763000034443
• NIH Device Record Key: bd538cac-b27d-40b7-a1b2-a6132397d87d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Causse / Flex H/A®
• Version Model Number: 0526
• 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: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000034443 [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 [Causse / Flex H/A®]

• 00763000034627: PROSTHESIS 0585 TRIAX INCUS NECROSIS
• 00763000034474: PROSTHESIS 0529 CAUSSE FLEX H/A TOTAL
• 00763000034467: PROSTHESIS 0528 CAUSSE MINI HD PARTIAL
• 00763000034450: PROSTHESIS 0527 CAUSSE H/A MINI HD TOTAL
• 00763000034443: PROSTHESIS 0526 CAUSSE FLEX H/A PARTIAL
• 00763000034436: PROSTHESIS 0525 CAUSSE FLEX H/A OFF TOTL
• 00763000034405: PROSTHESIS 0518 CAUSSE FLEX H/A OFF TOT