Moretz / Polycel®

GUDID 00763000033347

PROSTHESIS 1112180 MORETZ CAM H/A POLY

MEDTRONIC XOMED, INC.

Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total

• Primary Device ID: 00763000033347
• NIH Device Record Key: efc035ef-afb5-441d-8a34-ae20b04f10cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Moretz / Polycel®
• Version Model Number: 1112180
• 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	00763000033347 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K810707

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 [Moretz / Polycel®]

• 00763000035471: PROSTHESIS 1156372 MORETZ FOOTPLATE SHOE
• 00763000035372: PROSTHESIS 1156298 MORETZ MALL STRUT
• 00763000034771: PROSTHESIS 1112185 MORETZ CAM PRT 4.75MM
• 00763000034764: PROSTHESIS 1112175 MORETZ MUSH H/A PART
• 00763000033354: PROSTHESIS 1112184 MORETZ CAM PRT 10MM
• 00763000033347: PROSTHESIS 1112180 MORETZ CAM H/A POLY