FDA.reportPublic FDA data

Open Pivot™

Primary DI
00643169624986
Brand
Open Pivot™
Company
MEDTRONIC, INC.
Model
556
Device description
ACCY 556 HAND ROTATOR
Published
2025-05-30
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
00643169624986PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169624986006431696249866431696249860643169624986

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)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000422615SYNCHROMED®II8637-402021-04-11
00763000634094SYNCHROMED® II8637-202022-08-11
00763000634100SYNCHROMED® II8637-402022-08-11
00643169508149SYNCHROMED® II8637-202016-04-27
00643169508156SYNCHROMED® II8637-402016-04-27
00643169630505SYNCHROMED® II8637-202018-08-17
00643169630512SYNCHROMED® II8637-402018-08-17
00643169100824SYNCHROMED ® II8637-402016-04-27
00643169100831SYNCHROMED ® II8637-202016-04-27
00199150084036MiniMed Flex Starter KitMMT-8076B2026-07-19
00199150084043MiniMed Flex Starter KitMMT-8076C2026-07-19
00199150084050MiniMed Extended Supply KitMMT-445B2026-07-19
00199150084067MiniMed Extended Supply KitMMT-445C2026-07-19
00824846004721NABB12S95R52026-07-19
00824846004738NABB12S26R2026-07-19
00824846004028NABB5722R492026-07-16
00824846003151NABB9F19R82026-07-09
00763000520083N/AA712002021-07-23
00643169711761Micra™MC1VR01US2018-01-13
00824846003472NABB10L84R92026-07-04

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
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
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