FDA.reportPublic FDA data

NA

Primary DI
05415067042330
Brand
NA
Company
ST. JUDE MEDICAL, INC.
Model
905
Catalog number
905
Device description
Mechanical Heart Valve Sizer Set
Published
2023-02-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DTISIZER, HEART-VALVE, PROSTHESIS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTISizer, Heart-Valve, ProsthesisCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05414734010153PreviousGS10
05415067042330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734010153054147340101535414734010153
05415067042330054150670423305415067042330

GMDN Terms#

Term, Definition table
TermDefinition
Heart valve sizer, reusableA hand-held manual surgical instrument intended to be used during heart valve repair or replacement that enables evaluation of the valve opening (patient annulus) into which the appropriate sized annuloplasty ring or replacement valve will be implanted. It is typically available as a set of sizers in a range for the aortic, mitral, or tricuspid valve, and handles to which the sizers are attached; this handle may also be connected to the valve or ring holder to assist implantation. This is a reusable device intended to be sterilized prior to use.

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
00763000990657Mosaic Neo™ S310MNHMEDTRONIC, INC.DTI2026-04-13
00763000990664Mosaic Neo™ S310MNSMEDTRONIC, INC.DTI2026-04-13
00690103019643HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019650HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019674HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019698HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019704HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019711HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019728HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019735HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019742HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019759HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019766HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019773HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019780HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019797HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019803HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019810HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019827HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019834HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019841HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019858HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019889KONECT AVC SIZER 19MMEdwards Lifesciences LLCDTI2026-04-06
00690103019896KONECT AVC SIZER 21MMEdwards Lifesciences LLCDTI2026-04-06
00690103019902KONECT AVC SIZER 23MMEdwards Lifesciences LLCDTI2026-04-06
00690103019919KONECT AVC SIZER 25MMEdwards Lifesciences LLCDTI2026-04-06
00690103019926KONECT AVC SIZER 27MMEdwards Lifesciences LLCDTI2026-04-06
00690103185683SIZER FOR MODEL 5200 PHYSIO II RINGEdwards Lifesciences LLCDTI2026-04-06
00690103185690SIZER FOR MODEL 5200 PHYSIO II RINGEdwards Lifesciences LLCDTI2026-04-06
00690103185706SIZER FOR MODEL 5200 PHYSIO II RINGEdwards Lifesciences LLCDTI2026-04-06