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
05415067032195EnSite™ENSITE-FF-01ENSITE-FF-012021-01-06
05415067032201EnSite™ENSITE-R-FF-01ENSITE-R-FF-012021-01-06
05415067024732EnSite Precision™H702473H7024732020-07-22
05415067024695EnSite Precision™H702469H7024692016-12-20
05415067024701EnSite Precision™H702470H7024702016-12-20
05415067024756EnSite Precision™ Link, Sensor Enabled™H702475H7024752016-12-20
05415067054463Ampere™AMP-TFDM-01AMP-TFDM-012026-08-19
05415067054661TactiSys™TSQ-V1.8-TFDM-01TSQ-V1.8-TFDM-012026-08-19
05415067055651EnSite™ENSITE-D-FOCAL-01ENSITE-D-FOCAL-012026-08-19
05415067055668EnSite™ENSITE-D-PI-01ENSITE-D-PI-012026-08-19
05415067055675EnSite™ENSITE-PI-01ENSITE-PI-012026-08-19
05415067055682EnSite™ENSITE-FOCAL-01ENSITE-FOCAL-012026-08-19
05415067050724TriClip™TSGC0801TSGC08012025-12-11
05415067050908MitraClip™SGC0801SGC08012025-12-11
05415067051844Agilis™ NxT Steerable Introducer Dual-Reach™SI-1371-LSI-1371-L2025-02-07
05415067051851Agilis™ NxT Steerable Introducer Dual-Reach™SI-1371-MSI-1371-M2025-02-07
05415067050182Agilis™ NxT Steerable Introducer Dual-Reach™SI-1371-SSI-1371-S2024-08-15
05415067047748TriClip™TSGC0201TSGC02012024-04-12
05415067038487Aveir™LSCD201LSCD2012023-08-15
05415067036384Aveir™LSCD111LSCD1112023-03-03

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