Contegra®

Primary DI
00643169616844
Brand
Contegra®
Company
MEDTRONIC, INC.
Model
200SH14
Device description
CNDT 200SH14 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
00643169616844PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169616844006431696168446431696168440643169616844

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
Primary DIBrandModelCatalogPublished
00824846005445NA12T76R12026-07-30
00824846005469NABB2Q31R112026-07-30
00824846005667NABB9R33R162026-07-30
00824846006022NABB12S36R2026-07-30
00824846007944NABB12W03R12026-07-30
00613994746627ATTAIN SELECT™ II624890D022016-07-16
00763000862336MyCareLink™249552026-07-26
00763000060374LINQ II™LNQ222020-07-18
00763000422615SYNCHROMED®II8637-402021-04-11
00763000634094SYNCHROMED® II8637-202022-08-11
00763000634100SYNCHROMED® II8637-402022-08-11
00643169508149SYNCHROMED® II8637-202016-04-27
00643169508156SYNCHROMED® II8637-402016-04-27
00643169630505SYNCHROMED® II8637-202018-08-17
00643169630512SYNCHROMED® II8637-402018-08-17
00643169100824SYNCHROMED ® II8637-402016-04-27
00643169100831SYNCHROMED ® II8637-202016-04-27
00199150084036MiniMed Flex Starter KitMMT-8076B2026-07-19
00199150084043MiniMed Flex Starter KitMMT-8076C2026-07-19
00199150084050MiniMed Extended Supply KitMMT-445B2026-07-19

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
00643169616851Contegra®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