Causse / Polycel®

GUDID 00763000035488

PROSTHESIS 1156376 CAUSSE FLPL PARTIAL

MEDTRONIC XOMED, INC.

Ossicular prosthesis, partial

• Primary Device ID: 00763000035488
• NIH Device Record Key: 4a0b2200-421f-48d5-be84-27cb86ae976c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Causse / Polycel®
• Version Model Number: 1156376
• 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
• Length: 4.75 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4.75 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4.75 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4.75 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4.75 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4.75 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4.75 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4.75 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4.75 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4.75 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4.75 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000035488 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K823442

FDA Product Code

• LBM: POROUS POLYETHYLENE 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 [Causse / Polycel®]

• 00763000035488: PROSTHESIS 1156376 CAUSSE FLPL PARTIAL
• 00763000035082: PROSTHESIS 1131000 CAUSSE LOOP W/TENDON
• 00763000034801: PROSTHESIS 1112197 CAUSSE MALLEUS PARTL