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) (9) Pump, Infusion (FRN) (1)

Premarket Exempt

Clear

Galeo Pro - 00814384020215 Catalog Number : 389783

Device Description : Coronary Guidewire

Device Class :

Duns Number: 189689800

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 5

Galeo Pro - 00814384020239 Catalog Number : 389785

Device Description : Coronary Guidewire

Device Class :

Duns Number: 189689800

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 5

Galeo Pro - 00814384020253 Catalog Number : 389787

Device Description : Coronary Guidewire

Device Class :

Duns Number: 189689800

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 5

Galeo Pro - 00814384020277 Catalog Number : 389782

Device Description : Coronary Guidewire

Device Class :

Duns Number: 189689800

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 5

Galeo Pro - 00814384020291 Catalog Number : 389784

Device Description : Coronary Guidewire

Device Class :

Duns Number: 189689800

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 5

Galeo Pro - 00814384020314 Catalog Number : 389786

Device Description : Coronary Guidewire

Device Class :

Duns Number: 189689800

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 5

Galeo Pro - 00814384020338 Catalog Number : 389788

Device Description : Coronary Guidewire

Device Class :

Duns Number: 189689800

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 5

Galeo Pro - 00814384020352 Catalog Number : 389791

Device Description : Coronary Guidewire

Device Class :

Duns Number: 189689800

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 5

Conductor - 00814384020369 Catalog Number : 511920-001

Device Description : Extension Guidewire

Device Class :

Duns Number: 189689800

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 5

Hands Free Syringe - 00814384020383 Catalog Number : 411987-001

Device Description : Pouch of 1 sterile 20 mL syringe, stored inside a box of 20

Device Class :

Duns Number: 189689800

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

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