FDA.reportPublic FDA data

CARBOMEDICS PROSTHETIC HEART VALVES

Primary DI
08022057013965
Brand
CARBOMEDICS PROSTHETIC HEART VALVES
Company
CORCYM SRL
Model
VS2-1618
Published
2021-04-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
08022057013965PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08022057013965080220570139658022057013965

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

Regulatory Flags#

DUNS number
441454802
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
08022057015747JOSEPH LAMELAS Atrial Lift SystemMI-ALS-001MI-ALS-0012026-02-03
08022057015754CUFF Aortic Root Exposure DeviceMI-CUFF-001MI-CUFF-0012026-02-03
08022057015853SUTURE BELT Circumferential Suture OrganizerMI-ISBA-001MI-ISBA-0012026-02-03
08022057015860TIE Intracorporeal Knot Placement Assist and COLLAR Papillary Muscle ExposureMI-COTIE-001MI-COTIE-0012026-02-03
08022057015877JOSEPH LAMELAS Knot PusherMI-KP-001MI-KP-0012026-02-03
08022057015884DeTACH Aortic Cross Clamp Head-LargeMI-XCHL-851MI-XCHL-8512026-02-03
08022057015907DeTACH Aortic Cross Clamp Head-SmallMI-XCHS-551MI-XCHS-5512026-02-03
18022057015744JOSEPH LAMELAS Atrial Lift SystemMI-ALS-001MI-ALS-0012026-02-03
18022057015751CUFF Aortic Root Exposure DeviceMI-CUFF-001MI-CUFF-0012026-02-03
08022057015761JOSEPH LAMELAS Intercostal Retractor System KitMI-IRS-222MI-IRS-2222026-02-03
08022057015778JOSEPH LAMELAS Intercostal Retractor System Retractor RackMI-IRS-R-001MI-IRS-R-0012026-02-03
08022057015785JOSEPH LAMELAS Intercostal Retractor System Small Blade SetMI-IRS-SB-P01MI-IRS-SB-P012026-02-03
08022057015792JOSEPH LAMELAS Intercostal Retractor System Medium Blade SetMI-IRS-MB-P01MI-IRS-MB-P012026-02-03
08022057015808JOSEPH LAMELAS Intercostal Retractor System Large Blade SetMI-IRS-LB-P01MI-IRS-LB-P012026-02-03
08022057015815JOSEPH LAMELAS Intercostal Retractor System Extra Large Blade SetMI-IRS-XLB-P01MI-IRS-XLB-P012026-02-03
08022057015822JOSEPH LAMELAS Intercostal Retractor System Small Double Swivel Blade SetMI-IRS-SDSB-22MI-IRS-SDSB-222026-02-03
08022057015839JOSEPH LAMELAS Intercostal Retractor System Medium Double Swivel Blade SetMI-IRS-MDSB-22MI-IRS-MDSB-222026-02-03
08022057015846JOSEPH LAMELAS Intercostal Retractor System Sterilization TrayMI-IRS-T-22MI-IRS-T-222026-02-03
18022057015850SUTURE BELT Circumferential Suture OrganizerMI-ISBA-001MI-ISBA-0012026-02-03
18022057015867TIE Intracorporeal Knot Placement Assist and COLLAR Papillary Muscle ExposureMI-COTIE-001MI-COTIE-0012026-02-03

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