MOSAIC ULTRA™

GUDID 00643169402539

SIZERS 7308U MOSAIC ULTRA AORTIC 26L

MEDTRONIC, INC.

Heart valve annulus sizer, reusable
Primary Device ID00643169402539
NIH Device Record Key52a3fd0a-e96e-4e1e-9304-5fdcf7c09619
Commercial Distribution StatusIn Commercial Distribution
Brand NameMOSAIC ULTRA™
Version Model Number7308U
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169402539 [Primary]

FDA Product Code

DTISIZER, HEART-VALVE, PROSTHESIS

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00643169402539]

Moist Heat or Steam Sterilization


[00643169402539]

Moist Heat or Steam Sterilization


[00643169402539]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-09
Device Publish Date2025-05-30

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00613994959546 - Open Pivot™2025-06-09 ACCY 558 ACTUATOR PACKAGE AVG
00643169402539 - MOSAIC ULTRA™2025-06-09SIZERS 7308U MOSAIC ULTRA AORTIC 26L
00643169402539 - MOSAIC ULTRA™2025-06-09 SIZERS 7308U MOSAIC ULTRA AORTIC 26L
00643169402591 - MOSAIC™CINCH™2025-06-09 SIZERS 7308C MOSAIC CINCH AORTIC 26L
00643169525511 - CG Future™2025-06-09 SIZER SET 7638S CG FUTURE 26L

Trademark Results [MOSAIC ULTRA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MOSAIC ULTRA
MOSAIC ULTRA
78470205 3294682 Live/Registered
Medtronic, Inc.
2004-08-19

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