FDA.report

SJM™

Primary DI
05414734054072
Brand
SJM™
Company
ST. JUDE MEDICAL, INC.
Model
Holder Handle
Catalog number
B1000-H
Device description
Model B1000-H
Published
2016-03-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
DTISIZER, HEART-VALVE, PROSTHESIS

Product Code Classifications

CodeDeviceSpecialtyClass
DTISizer, Heart-Valve, ProsthesisCardiovascular1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05414734054072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05414734054072054147340540725414734054072

GMDN Terms

TermDefinition
Heart valve prosthesis sizer handleA hand-held manual surgical instrument intended to be used during cardiac valve repair or replacement as a handle to which an interchangeable valve sizer is attached to allow the surgeon to evaluate the valve opening (patient annulus) into which the appropriate sized annuloplasty ring or replacement valve will be implanted. The device is typically made of metal and/or plastic (e.g., polysulphone) and is straight and/or curved, rigid and/or flexible in design; this handle may also be connected to the valve or ring holder to assist implantation. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00The Sizer Set Model B1000 is supplied non-sterile. The sizer set may be stored indefinitely.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags

DUNS number
149818952
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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05415067051417Current™PFA-ECG-LNAMPFA-ECG-LNAM2026-01-06
05415067051516Current™PFA-GEN-01PFA-GEN-012026-01-06
05415067051554Current™PFA-ECG-CBLPFA-ECG-CBL2026-01-06
05415067051615Current™PFA-ECG-RNAMPFA-ECG-RNAM2026-01-06
05415067051721Current™PFA-GEN-CARTPFA-GEN-CART2026-01-06
05415067051752Current™PFA-R-GEN-01PFA-R-GEN-012026-01-06
05415067051813Current™GEN-3RD-RECGEN-3RD-REC2026-01-06
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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00690103019353AORTIC TRUE-SIZE OBTURATOR 19MMEdwards Lifesciences LLCDTI2026-02-13
00690103019360AORTIC TRUE-SIZE OBTURATOR 21MMEdwards Lifesciences LLCDTI2026-02-13
00690103019377AORTIC TRUE-SIZE OBTURATOR 23MMEdwards Lifesciences LLCDTI2026-02-13
00690103019384AORTIC TRUE-SIZE OBTURATOR 25MMEdwards Lifesciences LLCDTI2026-02-13
00690103019391AORTIC TRUE-SIZE OBTURATOR 27MMEdwards Lifesciences LLCDTI2026-02-13
00690103019407AORTIC TRUE-SIZE OBTURATOR 29MMEdwards Lifesciences LLCDTI2026-02-13
00690103019414AORTIC TRUE-SIZE OBTURATOR 31MMEdwards Lifesciences LLCDTI2026-02-13
00690103019278HEART VALVE SIZER ACCESSORYEdwards Lifesciences LLCDTI2026-02-11
00690103019285HEART VALVE SIZER ACCESSORYEdwards Lifesciences LLCDTI2026-02-11
00690103019292HEART VALVE SIZER ACCESSORYEdwards Lifesciences LLCDTI2026-02-11
00690103174755HEART VALVE SIZER ACCESSORYEdwards Lifesciences LLCDTI2026-02-11
00690103174762HEART VALVE SIZER ACCESSORYEdwards Lifesciences LLCDTI2026-02-11
00690103174779HEART VALVE SIZER ACCESSORYEdwards Lifesciences LLCDTI2026-02-11
00690103174786HEART VALVE SIZER ACCESSORYEdwards Lifesciences LLCDTI2026-02-11
00690103174793HEART VALVE SIZER ACCESSORYEdwards Lifesciences LLCDTI2026-02-11
00690103174809HEART VALVE SIZER ACCESSORYEdwards Lifesciences LLCDTI2026-02-11
00690103185775PERIMOUNT MAGNA EASE AORTIC SIZER 19MMEdwards Lifesciences LLCDTI2026-02-11
00690103185782PERIMOUNT MAGNA EASE AORTIC SIZER 21MMEdwards Lifesciences LLCDTI2026-02-11
00690103185799PERIMOUNT MAGNA EASE AORTIC SIZER 23MMEdwards Lifesciences LLCDTI2026-02-11
00690103185805PERIMOUNT MAGNA EASE AORTIC SIZER 25MMEdwards Lifesciences LLCDTI2026-02-11
00690103185812PERIMOUNT MAGNA EASE AORTIC SIZER 27MMEdwards Lifesciences LLCDTI2026-02-11
00690103185829PERIMOUNT MAGNA EASE AORTIC SIZER 29MMEdwards Lifesciences LLCDTI2026-02-11
00690103019261HEART VALVE SIZER ACCESSORYEdwards Lifesciences LLCDTI2026-02-10
00690103186307REPLICA SIZER FOR MAGNA MITRAL EASE VALVE MODEL 7300TFX, NON-STERILEEdwards Lifesciences LLCDTI2026-02-10
00690103186314CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE REPLICA SIZEREdwards Lifesciences LLCDTI2026-02-10
00690103186321REPLICA SIZER FOR MAGNA MITRAL EASE VALVE MODEL 7300TFX, NON-STERILEEdwards Lifesciences LLCDTI2026-02-10
00690103186338CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE REPLICA SIZEREdwards Lifesciences LLCDTI2026-02-10
00690103186345CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE REPLICA SIZEREdwards Lifesciences LLCDTI2026-02-10
00690103186352CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE REPLICA SIZEREdwards Lifesciences LLCDTI2026-02-10
00690103186369BARREL SIZER FOR MAGNA MITRAL EASE VALVE MODEL 7300TFX, NON-STERILEEdwards Lifesciences LLCDTI2026-02-10