Mortez

GUDID 00681490035767

PROSTHESIS 1156377 MORETZ PEG-TOP PART

MEDTRONIC XOMED, INC.

Ossicular prosthesis, partial

• Primary Device ID: 00681490035767
• NIH Device Record Key: d3563c0b-192b-4fba-87e3-8a1a72d5bd82
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mortez
• Version Model Number: 1156377
• 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
• 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: 4.75 Millimeter
• Length: 4.75 Millimeter
• Length: 4.75 Millimeter
• Length: 4.75 Millimeter
• Length: 4.75 Millimeter
• 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 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	00681490035767 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-06-23

On-Brand Devices [Mortez]

• 20681490041328: VENT TUBE 14642 10PK MICROBLUE PAIR 1.27
• 20681490041311: VENT TUBE 14641 5PK MICROBLUE TITAN 1.27
• 00681490035781: PROSTHESIS 1156379 MORETZ PEG-TOP TOTAL
• 00681490035774: PROSTHESIS 1156378 MORETZ STRUT/SHOE
• 00681490035767: PROSTHESIS 1156377 MORETZ PEG-TOP PART
• 00681490035743: PROSTHESIS 1156372 MORETZ FOOTPLATE SHOE
• 00681490035705: PROSTHESIS 1156359 MORETZ PEG-TOP PART
• 00681490035699: PROSTHESIS 1156358 MORETZ P-T OFFST PART
• 00681490035446: PROSTHESIS 1156302 MORETZ PEG-TOP OFFSET
• 00681490035439: PROSTHESIS 1156298 MORETZ MALL STRUT
• 00681490035422: PROSTHESIS 1156297 MORETZ MALLEUS STRUT
• 00681490035415: PROSTHESIS 1156296 MORETZ MALL STRUT
• 00681490033626: PROSTHESIS 1112297 MORETZ MALL STRUT STR
• 00681490033619: PROSTHESIS 1112296 MORETZ MALLEUS ANGLED
• 00681490033558: PROSTHESIS 1112185 MORETZ CAM PRT 4.75MM
• 00681490033541: PROSTHESIS 1112184 MORETZ CAM PRT 10MM
• 00681490033534: PROSTHESIS 1112183 MORETZ CAM H/A/FLPL
• 00681490033527: PROSTHESIS 1112182 MORETZ CAM H/A FLPL
• 00681490033503: PROSTHESIS 1112180 MORETZ CAM H/A POLY
• 00681490033497: PROSTHESIS 1112175 MORETZ MUSH H/A PART
• 00681490033466: PROSTHESIS 1112167 MORETZ MALL H/A PRT L
• 00681490033459: PROSTHESIS 1112165 MORETZ MALL H/A PAR R
• 00681490033442: PROSTHESIS 1112163 MORETZ MALL H/A TOT R
• 00681490033435: PROSTHESIS 1112162 MORETZ MALL H/A TOT L
• 20681490032708: VENT TUBE 1066177 10PK MORETZ TAB PAIR
• 20681490032210: VENT TUBE 1056705 5PK MORETZ TAB
• 20681490032197: VENT TUBE 1056177 5PK MORETZ TAB 1.27MM
• 00681490024839: PROSTHESIS 0574 MORETZ MUSHRM HEAD TOTAL
• 20763000039589: VENT TUBE 1056177 5PK MORETZ TAB 1.27MM