Coroneo Inc

Address:9250 AVENUE DU PARC, SUITE 514,MONTREAL, QC Quebec,CA

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Retractor (GAD) (8) Tape, Measuring, Rulers And Calipers (FTY) (1)

Premarket Exempt

Yes

Clear

Cor-Valv Atrial Retractor Cables with Fitting - 00817121000198 Catalog Number : 1011180

Device Description : The Cor-Valv Cable is intended to be used with the corresponding CORONEO Cor-Val The Cor-Valv Cable is intended to be used with the corresponding CORONEO Cor-Valv system retractor for retraction of heart tissue during cardiac surgery. This product is provided sterile in a sealed package, and consists one(1) cable that is single-use and disposable held by a plastic insert.

Device Class : 1

Duns Number: 255276362

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

Aortic Prosthesis Indexing Cone - 10817121000171 Catalog Number : 1010605

Device Description : The Aortic Prosthesis Indexing Cone is a medical device that is intended to be u The Aortic Prosthesis Indexing Cone is a medical device that is intended to be used to facilitate the location and cutting of two or three equally spaced features on an extremity of an aortic graft prosthesis having a diameter within the range of 20 mm to 34 mm.

Device Class : 1

Duns Number: 255276362

Premarket Exempt : Yes

Product Code : FTY

Prescription Use : Yes

Device Count : 1

COR-VALV Atrial Retractor - 10817121000256 Catalog Number : 1010684

Device Description : The Atrial Retractor is intended to retract atrial tissue during repair or repla The Atrial Retractor is intended to retract atrial tissue during repair or replacement of the mitral cardiac valve.

Device Class : 1

Duns Number: 255276362

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

Universal Clamp - 10817121000287 Catalog Number : 1100347

Device Description : The device is intended to be used to clamp surgical instruments to the adult tho The device is intended to be used to clamp surgical instruments to the adult thoracic retractors manufactured by CORONEO INC.

Device Class : 1

Duns Number: 255276362

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

Spreader Arm for Small Adult Sternum Retractor - 10817121000294 Catalog Number : 1010900

Device Description : The device is intended to be used for sternal retraction on adult patients.

Device Class : 1

Duns Number: 255276362

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

Spreader Arm - Rack Side (small) - 10817121000300 Catalog Number : 1011379

Device Description : The device component is intended to be used for sternal retraction on adult patients.

Device Class : 1

Duns Number: 255276362

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

Pinion - Large - 10817121000317 Catalog Number : 1011713

Device Description : The device component is intended to be used for sternal retraction on adult patients.

Device Class : 1

Duns Number: 255276362

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

Spreader Arm - Crank Side - 10817121000324 Catalog Number : 1010807

Device Description : The device is intended to be used for sternal retraction on adult patients.

Device Class : 1

Duns Number: 255276362

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

Spreader Arm - Rack Side (large) - 10817121000331 Catalog Number : 1011378

Device Description : The device component is intended to be used for sternal retraction on adult patients.

Device Class : 1

Duns Number: 255276362

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

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