FDA.reportPublic FDA data

KONECT AVC TRAY MODEL 1190

Primary DI
00690103201345
Brand
KONECT AVC TRAY MODEL 1190
Company
Edwards Lifesciences LLC
Model
TRAY1190
Catalog number
TRAY1190
Device description
SIZER TRAY FOR MODEL 1190 SIZERS 19 MM - 29 MM FOR THE KONECT RESILIA AORTIC VALVED CONDUIT
Published
2026-04-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00690103201345PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690103201345006901032013456901032013450690103201345

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)822-9837tech_support@edwards.com

Regulatory Flags#

DUNS number
134139174
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00690103205084FOGARTY120403FP120403FP2020-09-15
00690103218602SWAN-GANZ TRUE SIZE096F6096F6P2026-03-16
00690103218626SWAN-GANZ TRUE SIZE111F7111F7P2026-03-16
00690103218633SWAN-GANZ TRUE SIZE114F7114F7P2026-03-16
00690103000245SWAN-GANZ TRUE SIZE096F6096F6P2016-09-03
00690103000269SWAN-GANZ110F5110F52016-09-03
00690103000276SWAN-GANZ TRUE SIZE111F7111F7P2016-09-03
00690103000313SWAN-GANZ TRUE SIZE114F7114F7P2016-09-03
00690103220223TRIFORMIS RESILIA Tricuspid Valve11300T2511300T252026-05-28
00690103220230TRIFORMIS RESILIA Tricuspid Valve11300T2711300T272026-05-28
00690103220247TRIFORMIS RESILIA Tricuspid Valve11300T2911300T292026-05-28
00690103220254TRIFORMIS RESILIA Tricuspid Valve11300T3111300T312026-05-28
00690103220261TRIFORMIS RESILIA Tricuspid Valve11300T3311300T332026-05-28
00690103019643HEART VALVE ACCESSORY1170117019MM2026-04-06
00690103019650HEART VALVE ACCESSORY1170117021MM2026-04-06
00690103019674HEART VALVE ACCESSORY1170117025MM2026-04-06
00690103019698HEART VALVE ACCESSORY1170117029MM2026-04-06
00690103019704HEART VALVE ACCESSORY1174M1174M242026-04-06
00690103019711HEART VALVE ACCESSORY1174M1174M262026-04-06
00690103019728HEART VALVE ACCESSORY1174M1174M282026-04-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327602241NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327602296NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327602302NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327602326NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327602418NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663518NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663525NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663532NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663549NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663556NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663563NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
18257200028177PHOENIX SFSOrthofix US LLCFSM2026-07-17
18257200028207PHOENIX SFSOrthofix US LLCFSM2026-07-17
18257200028917FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200028924FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200028931FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200028948FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200028955FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200028979FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200028986FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200028993FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029006FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029013FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029020FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029280FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029846FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029853FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029860FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029877FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029884FIREBIRD SFSOrthofix US LLCFSM2026-07-17