Freestyle™ 7990

GUDID 00763000613679

OBTURATORS 7990SET FREESTYLE EU MDR

MEDTRONIC, INC.

Heart valve annulus sizer, reusable
Primary Device ID00763000613679
NIH Device Record Keybfb98476-99e4-4dee-b1fb-e39115732004
Commercial Distribution StatusIn Commercial Distribution
Brand NameFreestyle™ 7990
Version Model Number7990SET
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
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
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
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
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
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 Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000613679 [Primary]

FDA Product Code

DTISIZER, HEART-VALVE, PROSTHESIS

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00763000613679]

Moist Heat or Steam Sterilization


[00763000613679]

Moist Heat or Steam Sterilization


[00763000613679]

Moist Heat or Steam Sterilization


[00763000613679]

Moist Heat or Steam Sterilization


[00763000613679]

Moist Heat or Steam Sterilization


[00763000613679]

Moist Heat or Steam Sterilization


[00763000613679]

Moist Heat or Steam Sterilization


[00763000613679]

Moist Heat or Steam Sterilization


[00763000613679]

Moist Heat or Steam Sterilization


[00763000613679]

Moist Heat or Steam Sterilization


[00763000613679]

Moist Heat or Steam Sterilization


[00763000613679]

Moist Heat or Steam Sterilization


[00763000613679]

Moist Heat or Steam Sterilization


[00763000613679]

Moist Heat or Steam Sterilization


[00763000613679]

Moist Heat or Steam Sterilization


[00763000613679]

Moist Heat or Steam Sterilization


[00763000613679]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-24
Device Publish Date2025-02-15

Devices Manufactured by MEDTRONIC, INC.

00763000963040 - N/A2025-02-25 ADAPTOR 64001 1X4 MVMT POCKET MDR US
00763000963057 - N/A2025-02-25 ADAPTOR 64002 2X4 MVMT POCKET MDR US
00643169673342 - Z22025-02-24 CATHETER Z26COLLINS Z2 6F 100CM COLIN
00763000613679 - Freestyle™ 79902025-02-24OBTURATORS 7990SET FREESTYLE EU MDR
00763000613679 - Freestyle™ 79902025-02-24 OBTURATORS 7990SET FREESTYLE EU MDR
20763000998008 - NA2025-02-24 CUSTOM PACK BB12H69R1 10PK PSI IL AC PT
00763000574598 - NA2025-02-18 COMMUNICATOR TM90T0 PROX US EMANUAL
00763000579388 - N/A2025-02-18 TELEMETRY MODULE TM90Q0 ISTIM X US
00763000879297 - NA2025-02-18 TELEMETRY TM90Q0 ISTIM X US EMAN

Trademark Results [Freestyle]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FREESTYLE
FREESTYLE
98504816 not registered Live/Pending
Tom's of Maine, Inc.
2024-04-17
FREESTYLE
FREESTYLE
98281125 not registered Live/Pending
Freestyle Software Inc.
2023-11-21
FREESTYLE
FREESTYLE
98220292 not registered Live/Pending
AUGUSTA SPORTSWEAR, INC.
2023-10-12
FREESTYLE
FREESTYLE
97601152 not registered Live/Pending
Mimetics Inc.
2022-09-21
FREESTYLE
FREESTYLE
97353950 not registered Live/Pending
Benjamin B. Ryan
2022-04-08
FREESTYLE
FREESTYLE
97108607 not registered Live/Pending
Nor'wood Limited, Inc.
2021-11-04
FREESTYLE
FREESTYLE
97102656 not registered Live/Pending
Somnetics International, Inc.
2021-11-01
FREESTYLE
FREESTYLE
97017205 not registered Live/Pending
Hebe Studio Ltd.
2021-09-08
FREESTYLE
FREESTYLE
90980881 not registered Live/Pending
Real Big Waves LLC
2020-10-21
FREESTYLE
FREESTYLE
90978857 not registered Live/Pending
Dad Provisions, Inc.
2021-07-28
FREESTYLE
FREESTYLE
90853142 not registered Live/Pending
Dad Provisions, Inc.
2021-07-28
FREESTYLE
FREESTYLE
90764538 not registered Live/Pending
Firebox Outdoors, LLC
2021-06-09

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.