Contegra®

Primary DI
00643169298637
Brand
Contegra®
Company
MEDTRONIC, INC.
Model
200H14
Device description
CNDT 200H14 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
00643169298637PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169298637006431692986376431692986370643169298637

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
00199150070114NAC320LBBL452026-04-13
00199150070121NAC320LBBL482026-04-13
00199150070138NAC320LBBS452026-04-13
00199150070145NAC320LBBS482026-04-13
00613994764546SHERPA NX BALANCEDSB8JR4052016-07-31
00613994764577SHERPA NX BALANCEDSB8JR3552016-07-31
00613994765055SHERPA NX BALANCEDSB8JL5052016-07-31
00613994765116SHERPA NX BALANCEDSB8JL4052016-07-31
00613994765147SHERPA NX BALANCEDSB8JL3552016-07-31
00613994766458SHERPA NX BALANCEDSB8AL1052016-06-12
00613994766526SHERPA NX BALANCEDSB8AR2052016-06-12
00613994766557SHERPA NX BALANCEDSB8AR1052016-06-12
00613994767158SHERPA NX BALANCEDSB8EBU4552016-06-12
00613994767196SHERPA NX BALANCEDSB8EBU4052016-06-12
00613994767240SHERPA NX BALANCEDSB8EBU3552016-06-12
00613994768018LauncherLA8JL5052016-04-08
00613994768124LauncherLA8JL4052016-04-15
00613994768308LauncherLA8JR4052016-09-01
00613994768353LauncherLA8JR3552016-04-07
00613994769497LauncherLA8AR2052016-04-16

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
00643169298620Contegra®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