FDA.reportPublic FDA data

Mitroflow Aortic Handle

Primary DI
00896208000078
Brand
Mitroflow Aortic Handle
Company
Corcym Canada Corp
Model
AH-11
Published
2021-04-08
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
DWSINSTRUMENTS, SURGICAL, CARDIOVASCULAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00896208000078PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00896208000078008962080000788962080000780896208000078

GMDN Terms#

Term, Definition table
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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
204322622
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
00896208000795PERCEVAL PLUSPVF-S2021-01-26
00896208000801PERCEVAL PLUSPVF-M2021-01-26
00896208000818PERCEVAL PLUSPVF-L2021-01-26
00896208000825PERCEVAL PLUSPVF-XL2021-01-26
00896208000528CROWN PRTCNA232016-08-08
00896208000535CROWN PRTCNA252016-08-08
00896208000542CROWN PRTCNA272016-08-08
00896208000412PERCEVALPVS21PVS212016-02-25
00896208000429PERCEVALPVS23PVS232016-02-25
00896208000436PERCEVALPVS25PVS252016-02-25
00896208000443PERCEVALPVS27PVS272016-02-25
08022057014924MITROFLOW VALSALVA CONDUITMVC262014-09-22
08022057014931MITROFLOW VALSALVA CONDUITMVC282014-09-22
00896208000108MITROFLOWLXA212014-09-19
00896208000115MITROFLOWLXA232014-09-19
00896208000122MITROFLOWLXA252014-09-19
00896208000139MITROFLOWLXA272014-09-19
00896208000153MITROFLOWDLA192014-09-19
00896208000160MITROFLOWDLA212014-09-19
00896208000177MITROFLOWDLA232014-09-19

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