Contegra®

Primary DI
00643169616851
Brand
Contegra®
Company
MEDTRONIC, INC.
Model
200SH16
Device description
CNDT 200SH16 CONTEGRA SUPP HDE
Published
2015-10-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MWHpulmonic valved conduit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MWHPulmonic Valved ConduitUnknownf

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H020003030

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H020003030

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169616851PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169616851006431696168516431696168510643169616851

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary heart valve bioprosthesisA sterile xenograft (e.g., porcine or bovine heart valve) intended to be implanted in a patient during open heart surgery to repair/replace a dysfunctional pulmonary heart valve, or to replace a pulmonary valve in patients undergoing a pulmonary autograft (Ross) procedure. It is processed to render the tissue in the valve non-viable; it may be tissue only, or tissue attached to a metal or synthetic polymer framework. The device is typically used to treat acquired or congenital valvular disease.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00763000923792Monitor Power CordMCS1622PC2026-09-25
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00763000368470Aurora EV-ICD™ MRI SureScan™DVEA3E42023-11-02
00763000001513Primo MRI™ DR SureScan™DDMD3D42018-06-02
00763000001551Primo MRI™ VR SureScan™DVMD3D42018-06-02
00763000059491Evera MRI™ XT DR SureScan®DDMB1D42017-10-20
00763000059651Viva™ Quad XT CRT-DDTBA1QQ2017-10-21
00763000059668Viva™ XT CRT-DDTBA1D42017-10-21
00763000059705Evera MRI™ S DR SureScan®DDMC3D42017-10-21
00643169314092Evera MRI™ XT DR SureScan®DDMB1D42015-09-21
00643169314153Evera MRI™ XT VR SureScan®DVMB1D42015-09-21
00643169720497Evera MRI™ XT DR SureScan®DDMB1D42017-09-15
00643169735637Percepta™ CRT-P MRI SureScan™W1TR012017-06-18
00643169735644Percepta™ Quad CRT-P MRI SureScan™W4TR012017-06-18
00643169735651Serena™ CRT-P MRI SureScan™W1TR022017-06-18
00643169735668Serena™ Quad CRT-P MRI SureScan™W4TR022017-06-18
00643169735675Solara™ CRT-P MRI SureScan™W1TR032017-06-18
00643169891401Percepta™ CRT-P MRI SureScan™W1TR012017-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00192896090682AUTO LOCK TOURNIQUETSONTEC INSTRUMENTS, INC.MWH2019-03-07
00643169616837Contegra®MEDTRONIC, INC.MWH2015-10-09
00643169616844Contegra®MEDTRONIC, INC.MWH2015-10-09
00643169616868Contegra®MEDTRONIC, INC.MWH2015-10-09
00643169616875Contegra®MEDTRONIC, INC.MWH2015-10-09
00643169616882Contegra®MEDTRONIC, INC.MWH2015-10-09
00643169616899Contegra®MEDTRONIC, INC.MWH2015-10-09
00643169616905Contegra®MEDTRONIC, INC.MWH2015-10-09
00643169616912Contegra®MEDTRONIC, INC.MWH2015-10-09
00643169616929Contegra®MEDTRONIC, INC.MWH2015-10-09
00643169616936Contegra®MEDTRONIC, INC.MWH2015-10-09
00643169616943Contegra®MEDTRONIC, INC.MWH2015-10-09
00643169298538Contegra®MEDTRONIC, INC.MWH2014-09-23
00643169298545Contegra®MEDTRONIC, INC.MWH2014-09-23
00643169298552Contegra®MEDTRONIC, INC.MWH2014-09-23
00643169298569Contegra®MEDTRONIC, INC.MWH2014-09-23
00643169298576Contegra®MEDTRONIC, INC.MWH2014-09-23
00643169298583Contegra®MEDTRONIC, INC.MWH2014-09-23
00643169298590Contegra®MEDTRONIC, INC.MWH2014-09-23
00643169298606Contegra®MEDTRONIC, INC.MWH2014-09-23
00643169298613Contegra®MEDTRONIC, INC.MWH2014-09-23
00643169298620Contegra®MEDTRONIC, INC.MWH2014-09-23
00643169298637Contegra®MEDTRONIC, INC.MWH2014-09-23
00643169298644Contegra®MEDTRONIC, INC.MWH2014-09-23
00643169357112Contegra®MEDTRONIC, INC.MWH2014-09-23
00643169357129Contegra®MEDTRONIC, INC.MWH2014-09-23
00643169357136Contegra®MEDTRONIC, INC.MWH2014-09-23
00643169357143Contegra®MEDTRONIC, INC.MWH2014-09-23
00643169357150Contegra®MEDTRONIC, INC.MWH2014-09-23
00643169357167Contegra®MEDTRONIC, INC.MWH2014-09-23