Mortez

GUDID 20763000039589

VENT TUBE 1056177 5PK MORETZ TAB 1.27MM

MEDTRONIC XOMED, INC.

Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube

• Primary Device ID: 20763000039589
• NIH Device Record Key: 8b85b189-f8aa-4d9a-9ed6-7a23736a1257
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mortez
• Version Model Number: 1056177
• 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

Device Dimensions

• Lumen/Inner Diameter: 1.27 Millimeter
• Lumen/Inner Diameter: 1.27 Millimeter
• Lumen/Inner Diameter: 1.27 Millimeter
• Lumen/Inner Diameter: 1.27 Millimeter
• Lumen/Inner Diameter: 1.27 Millimeter
• Lumen/Inner Diameter: 1.27 Millimeter
• Lumen/Inner Diameter: 1.27 Millimeter
• Lumen/Inner Diameter: 1.27 Millimeter
• Lumen/Inner Diameter: 1.27 Millimeter
• Lumen/Inner Diameter: 1.27 Millimeter
• Lumen/Inner Diameter: 1.27 Millimeter
• Lumen/Inner Diameter: 1.27 Millimeter
• Lumen/Inner Diameter: 1.27 Millimeter
• Lumen/Inner Diameter: 1.27 Millimeter
• Lumen/Inner Diameter: 1.27 Millimeter
• Lumen/Inner Diameter: 1.27 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000039585 [Primary]
GS1	20763000039589 [Package]; Contains: 00763000039585; Package: PK [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151067

FDA Product Code

• ETD: TUBE, TYMPANOSTOMY

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: 2020-05-01
• Device Publish Date: 2020-04-23

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