Contegra®

Primary DI
00643169298620
Brand
Contegra®
Company
MEDTRONIC, INC.
Model
200H16
Device description
CNDT 200H16 CONTEGRA GBR1 HDE TEMP IND
Published
2014-09-23
Public version status
Update
Distribution status
Not 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
H020003022

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H020003022

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169298620PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169298620006431692986206431692986200643169298620

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
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00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30
00199150083763NA7J79R92026-05-30
00199150083794NABB8P50R62026-05-30
00199150083800NABB12E50R62026-05-30
00199150083817NABB10Z66R152026-05-30
00199150083893NA7E60R32026-05-30
00199150083985NABB12V61R12026-05-30
00199309002416N/ATH91DBS2026-05-29
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23

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
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
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