Contegra®

GUDID 00613994600172

CNDT 200SH16 CONTEGRA SUPP HDE GBR1-PS

MEDTRONIC, INC.

Pulmonary heart valve bioprosthesis
Primary Device ID00613994600172
NIH Device Record Key85e87445-6f6c-4122-8347-bb0bb5546b82
Commercial Distribution Discontinuation2018-10-05
Commercial Distribution StatusNot in Commercial Distribution
Brand NameContegra®
Version Model Number200SH16
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
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

Device Dimensions

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

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994600172 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MWHpulmonic valved conduit

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-12-19
Device Publish Date2014-09-23

On-Brand Devices [Contegra®]

00613994600349CNDT 200H22 CONTEGRA UNSUPP HDE PS
00613994600325CNDT 200H20 CONTEGRA UNSUPP HDE PS
00613994600301CNDT 200H18 CONTEGRA UNSUPP HDE PS
00613994600295CNDT 200H16 CONTEGRA UNSUPP HDE GBR1-PS
00613994600288CNDT 200H16 CONTEGRA UNSUPP HDE PS
00613994600271CNDT 200H14 CONTEGRA UNSUPP HDE GBR1-PS
00613994600257CNDT 200H12 CONTEGRA UNSUPP HDE GBR1-PS
00613994600226CNDT 200SH22 CONTEGRA SUPP HDE PS
00613994600202CNDT 200SH20 CONTEGRA SUPP HDE PS
00613994600189CNDT 200SH18 CONTEGRA SUPP HDE PS
00613994600172CNDT 200SH16 CONTEGRA SUPP HDE GBR1-PS
00613994600165CNDT 200SH16 CONTEGRA SUPP HDE PS
00613994600158CNDT 200SH14 CONTEGRA SUPP HDE GBR1-PS
00613994600141CNDT 200SH14 CONTEGRA SUPP HDE PS
00613994600134CNDT 200SH12 CONTEGRA SUPP HDE GBR1-PS
00643169616943CNDT 200H22 CONTEGRA UNSUPP HDE
00643169616936CNDT 200H20 CONTEGRA UNSUPP HDE
00643169616929CNDT 200H18 CONTEGRA UNSUPP HDE
00643169616912CNDT 200H16 CONTEGRA UNSUPP HDE
00643169616905CNDT 200H14 CONTEGRA UNSUPP HDE
00643169616899CNDT 200H12 CONTEGRA UNSUPP HDE
00643169616882CNDT 200SH22 CONTEGRA SUPP HDE
00643169616875CNDT 200SH20 CONTEGRA SUPP HDE
00643169616868CNDT 200SH18 CONTEGRA SUPP HDE
00643169616851CNDT 200SH16 CONTEGRA SUPP HDE
00643169616844CNDT 200SH14 CONTEGRA SUPP HDE
00643169616837CNDT 200SH12 CONTEGRA SUPP HDE
00643169357167CNDT 200SH22 CONTEGRA GBR1 HDE TEMP IND
00643169357150CNDT 200SH20 CONTEGRA GBR1 HDE TEMP IND
00643169357143CNDT 200SH18 CONTEGRA GBR1 HDE TEMP IND
00643169357136CNDT 200H22 CONTEGRA GBR1 HDE TEMP IND
00643169357129CNDT 200H20 CONTEGRA GBR1 HDE TEMP IND
00643169357112CNDT 200H18 CONTEGRA GBR1 HDE TEMP IND
00643169298644CNDT 200H12 CONTEGRA GBR1 HDE TEMP IND
00643169298637CNDT 200H14 CONTEGRA GBR1 HDE TEMP IND
00643169298620CNDT 200H16 CONTEGRA GBR1 HDE TEMP IND
00643169298613CNDT 200H18 CONTEGRA GBR3 HDE TEMP IND
00643169298606CNDT 200H20 CONTEGRA GBR3 HDE TEMP IND
00643169298590CNDT 200H22 CONTEGRA GBR3 HDE TEMP IND
00643169298583CNDT 200SH12 CONTEGRA GBR1 HDE TEMP IND
00643169298576CNDT 200SH14 CONTEGRA GBR1 HDE TEMP IND
00643169298569CNDT 200SH16 CONTEGRA GBR1 HDE TEMP IND
00643169298552CNDT 200SH18 CONTEGRA GBR3 HDE TEMP IND
00643169298545CNDT 200SH20 CONTEGRA GBR3 HDE TEMP IND
00643169298538CNDT 200SH22 CONTEGRA GBR3 HDE TEMP IND

Trademark Results [Contegra]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CONTEGRA
CONTEGRA
78183612 2833310 Live/Registered
CONTEGRA SYSTEMS, INC.
2002-11-11
CONTEGRA
CONTEGRA
75773312 2649853 Live/Registered
MEDTRONIC, INC.
1999-08-11
CONTEGRA
CONTEGRA
75413341 2322266 Live/Registered
Contegra Inc.
1997-12-31

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