Causse / Flex H/A®

GUDID 00763000034467

PROSTHESIS 0528 CAUSSE MINI HD PARTIAL

MEDTRONIC XOMED, INC.

Ossicular prosthesis, partial

• Primary Device ID: 00763000034467
• NIH Device Record Key: 6f5bf0f2-f19d-46dd-b7a6-758a9ee18ccd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Causse / Flex H/A®
• Version Model Number: 0528
• 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
• 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
• Length: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000034467 [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