FDA.report

FREEDOM SOLO

Primary DI
08022057014894
Brand
FREEDOM SOLO
Company
SORIN GROUP ITALIA SRL
Model
ICV1237
Published
2021-04-02
Public version status
New
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

Product Codes

CodeName
DTISIZER, HEART-VALVE, PROSTHESIS

Product Code Classifications

CodeDeviceSpecialtyClass
DTISizer, Heart-Valve, ProsthesisCardiovascular1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08022057014894PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08022057014894080220570148948022057014894

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
428011907
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
38033178102934DHF02 HEMOCONCENTRATOR2015-07-15
38033178102941DHF06 HEMOCONCENTRATOR2015-07-15
38033178233638SH14 - HEMOCONCENTRATOR2015-07-15
38033178019621Aortic Root cannulaAR-131142026-03-06
38033178019638Aortic Root cannulaAR-191142026-03-06
38033178019645Vessel CannulaVC-120002026-03-06
38033178019652Vessel CannulaVC-120102026-03-06
38033178019669Vessel CannulaVC-120202026-03-06
38033178019676Vessel CannulaVC-220102026-03-06
38033178017191Cardioplegia CannulaAR-110122026-02-11
38033178017207Cardioplegia CannulaAR-110142026-02-11
38033178017214Cardioplegia CannulaAR-110162026-02-11
38033178017221Cardioplegia CannulaAR-110182026-02-11
38033178017238Cardioplegia CannulaAR-111122026-02-11
38033178017245Cardioplegia CannulaAR-111142026-02-11
38033178017252Cardioplegia CannulaAR-111162026-02-11
38033178017269Cardioplegia CannulaAR-170122026-02-11
38033178017276Cardioplegia CannulaAR-170142026-02-11
38033178017313Cardioplegia CannulaAX-303212026-02-11
38033178018075Coronary Sinus CannulaRCM-141152026-02-11

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