FDA.reportPublic FDA data

FLEXIBLE HANDLE

Primary DI
00690103186437
Brand
FLEXIBLE HANDLE
Company
Edwards Lifesciences LLC
Model
1173
Catalog number
1173
Device description
FLEXIBLE HANDLE
Published
2024-10-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00690103186437PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690103186437006901031864376901031864370690103186437

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry place.

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
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
00690103210132MITRIS Handle 1140MEdwards Lifesciences LLCDTJ2024-10-18
006901032194011141M MITRIS RESILIA Mitral Valve HandleEdwards Lifesciences LLCDTJ2024-07-10
05415067042279Regent™ST. JUDE MEDICAL, INC.DTJ2023-02-17
05415067042293Masters Series™ST. JUDE MEDICAL, INC.DTJ2023-02-17