CONCERT MEDICAL, LLC

Address:77 ACCORD PARK DR.,NORWELL,MA,02061,US

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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

Wire, Guide, Catheter (DQX) (5) Pump, Infusion (FRN) (2)

Premarket Exempt

Clear

Hands Free Syringe - 00814384020406 Catalog Number : 411983-001

Device Description : 1 Foot pedal unit that controls injection/aspiration of HFS Sterile Syringe.

Device Class : 2

Duns Number: 189689800

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

Hands Free Syringe - 00814384020413 Catalog Number : 411984-001

Device Description : 1 Motor Housing unit that injects/aspirates the HFS Sterile Syringe

Device Class : 2

Duns Number: 189689800

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

S-Wire Guidewire System - 00814384020437 Catalog Number :

Device Description : The S-Wire Guidewire System is a sterile, single-use guidewire intended to facil The S-Wire Guidewire System is a sterile, single-use guidewire intended to facilitate the introduction and placement of interventional devices within the chambers of the heart, including those in trans-catheter aortic valve implantation (TAVI) procedures.

Device Class :

Duns Number: 189689800

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 5

Conductor - 00814384020451 Catalog Number : 511950-006

Device Description : Conductor Hydro Extra Support

Device Class :

Duns Number: 189689800

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 5

Conductor - 00814384020468 Catalog Number : 511950-002

Device Description : Conductor Hydro Floppy

Device Class :

Duns Number: 189689800

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 5

Conductor - 00814384020482 Catalog Number : 511950-003

Device Description : Conductor Hydro Medium

Device Class :

Duns Number: 189689800

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 5

Conductor - 00814384020505 Catalog Number : 511950-001

Device Description : Conductor Hydro Very Floppy

Device Class :

Duns Number: 189689800

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 5

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