FDA.reportPublic FDA data

Regent™

Primary DI
05415067042279
Brand
Regent™
Company
ST. JUDE MEDICAL, INC.
Model
AG-RHR
Catalog number
AG-RHR
Device description
Replacement Holder/Rotators
Published
2023-02-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
05414734009256PreviousGS10
05415067042279PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734009256054147340092565414734009256
05415067042279054150670422795415067042279

GMDN Terms#

Term, Definition table
TermDefinition
Heart valve prosthesis holder, single-useA 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 single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
149818952
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
05414734400596MTS™118311832015-04-25
05414734403382NA724172412015-03-24
05414734405157SJM™162716272015-03-12
05415067016560SJM™303230322015-07-29
05415067018533SJM™121312132015-07-29
05415067018854SJM™121412142015-07-29
05415067027863NA703270322017-11-16
05415067052933Current™A-UNI-PF-CBLA-UNI-PF-CBL2026-04-20
05415067053893Current™PFA-GEN-V102PFA-GEN-V1022026-04-20
05415067056108EnSite™ENSITE-RL-MPENSITE-RL-MP2026-04-17
05415067051516Current™PFA-GEN-01PFA-GEN-012026-01-06
05415067051752Current™PFA-R-GEN-01PFA-R-GEN-012026-01-06
05415067053022Volt™ PFA Sensor Enabled™A-VOLT-01A-VOLT-012026-01-06
05414734400749Tennafix™120512052015-09-08
05414734405355SJM™301330132015-04-25
05415067016119NA231123112015-03-12
05415067016126SJM™23162316ANS2015-03-12
05415067016133SJM™23212321ANS2015-04-22
05415067016140NA232623262015-04-22
05415067016683NA231623162015-09-08

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
006901032194011141M MITRIS RESILIA Mitral Valve HandleEdwards Lifesciences LLCDTJ2024-07-10
05415067042293Masters Series™ST. JUDE MEDICAL, INC.DTJ2023-02-17