FDA.reportPublic FDA data

1141M MITRIS RESILIA Mitral Valve Handle

Primary DI
00690103219401
Brand
1141M MITRIS RESILIA Mitral Valve Handle
Company
Edwards Lifesciences LLC
Model
1141M
Catalog number
1141M
Device description
STAINLESS STEEL REUSABLE HANDLE FOR MITRIS
Published
2024-07-10
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
DTJHolder, Heart-Valve, Prosthesis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTJHolder, Heart-Valve, ProsthesisCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00690103219401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690103219401006901032194016901032194010690103219401

GMDN Terms#

Term, Definition table
TermDefinition
Heart valve prosthesis holder, reusableA hand-held, non-powered, invasive surgical instrument designed to hold a cardiac (heart) valve prosthesis or a cardiac annuloplasty ring at, or in proximity to, its site of implantation during surgery. It includes an implant mounting/containing feature and a handle; implantable devices are not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)822-9637tech_support@edwards.com

Regulatory Flags#

DUNS number
134139174
Device count
1
Premarket exempt
true
Combination product
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
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
00690103019735HEART VALVE ACCESSORY1174M1174M302026-04-06
00690103019742HEART VALVE ACCESSORY1174M1174M322026-04-06
00690103019759HEART VALVE ACCESSORY1174M1174M342026-04-06
00690103019766HEART VALVE ACCESSORY1174M1174M362026-04-06
00690103019773HEART VALVE ACCESSORY1174M1174M382026-04-06
00690103019780HEART VALVE ACCESSORY1174M1174M402026-04-06
00690103019797HEART VALVE ACCESSORY1175T1175T262026-04-06
00690103019803HEART VALVE ACCESSORY1175T1175T282026-04-06
00690103019810HEART VALVE ACCESSORY1175T1175T302026-04-06
00690103019827HEART VALVE ACCESSORY1175T1175T322026-04-06
00690103019834HEART VALVE ACCESSORY1175T1175T342026-04-06
00690103019841HEART VALVE ACCESSORY1175T1175T362026-04-06
00690103019858HEART VALVE ACCESSORY1175T1175T382026-04-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00613994163516Annuloplasty HandleMEDTRONIC, INC.DTJ2025-12-22
00613994862488Annuloplasty HandleMEDTRONIC, INC.DTJ2025-12-22
00643169525610Annuloplasty HandleMEDTRONIC, INC.DTJ2025-12-22
00643169525634Annuloplasty HandleMEDTRONIC, INC.DTJ2025-12-22
00643169525641Annuloplasty HandleMEDTRONIC, INC.DTJ2025-12-22
00721902450358Valve HandleMEDTRONIC, INC.DTJ2025-12-22
00885074394848Valve HandleMEDTRONIC, INC.DTJ2025-12-22
00763000658960Profile 3D™MEDTRONIC, INC.DTJ2025-08-21
00763000658953Profile 3D™MEDTRONIC, INC.DTJ2025-07-19
00763000658977Profile 3D™MEDTRONIC, INC.DTJ2025-07-19
00643169739246Avalus™MEDTRONIC, INC.DTJ2025-05-31
00613994163523Duran AnCoreMEDTRONIC, INC.DTJ2025-05-30
00643169525627Annuloplasty HandleMEDTRONIC, INC.DTJ2025-05-30
00643169554139Valve HandleMEDTRONIC, INC.DTJ2025-05-30
00643169554146Valve HandleMEDTRONIC, INC.DTJ2025-05-30
00643169624955Open Pivot™MEDTRONIC, INC.DTJ2025-05-30
00643169624986Open Pivot™MEDTRONIC, INC.DTJ2025-05-30
00763000612351Annuloplasty HandleMEDTRONIC, INC.DTJ2025-03-20
00763000612368Annuloplasty HandleMEDTRONIC, INC.DTJ2025-03-20
00763000613648NAMEDTRONIC, INC.DTJ2025-03-03
00763000613655NAMEDTRONIC, INC.DTJ2025-03-03
00763000582906Valve Handle 7420MEDTRONIC, INC.DTJ2025-02-23
00690103019063HEART VALVE HANDLE ACCESSORYEdwards Lifesciences LLCDTJ2024-10-18
00690103019339HEART VALVE ACCESSOREdwards Lifesciences LLCDTJ2024-10-18
00690103166989HEART VALVE ACCESSOREdwards Lifesciences LLCDTJ2024-10-18
00690103177701A HANDLE COMPATIBLE WITH RING HOLDERS MODELS 5100, 4900, 4100, 4200, 4450 AND 46Edwards Lifesciences LLCDTJ2024-10-18
00690103186437FLEXIBLE HANDLEEdwards Lifesciences LLCDTJ2024-10-18
00690103210132MITRIS Handle 1140MEdwards Lifesciences LLCDTJ2024-10-18
05415067042279Regent™ST. JUDE MEDICAL, INC.DTJ2023-02-17
05415067042293Masters Series™ST. JUDE MEDICAL, INC.DTJ2023-02-17