Causse / Polycel®

GUDID 00763000035488

PROSTHESIS 1156376 CAUSSE FLPL 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: 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