AESDEX, LLC

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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

Staple, Implantable (GDW) (4) Clip, Implantable (FZP) (3) Instruments, Surgical, Cardiovascular (DWS) (1) Stapler, Surgical (GAG) (1)

Premarket Exempt

No Yes

Clear

Cardica PAS-Port Proximal Anastomosis System - 11814900000017 Catalog Number : FG-000001

Device Description : PAS-Port Proximal Anastomosis System

Device Class : 2

Duns Number: 081132841

Premarket Exempt : No

Product Code : FZP

Prescription Use : Yes

Device Count : 1

Cardica Vein/Aorta Gauge - 11814900000031 Catalog Number : FG-000003

Device Description : The Vein/Aorta Gauge is a product that will assess outside diameter and wall thi The Vein/Aorta Gauge is a product that will assess outside diameter and wall thickness of a graft conduit and the outside diameter of a target vessel for reference only.

Device Class : 1

Duns Number: 081132841

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

Cardica C-Port xA Plus Anastomosis System - 11814900001007 Catalog Number : FG-000100

Device Description : C-Port xA Plus Anastomosis System

Device Class : 2

Duns Number: 081132841

Premarket Exempt : No

Product Code : FZP

Prescription Use : Yes

Device Count : 1

Cardica C-Port Flex-A Plus Distal Anastomosis System - 11814900001502 Catalog Number : FG-000150

Device Description : C-Port FLEX-A Plus Distal Anastomosis System

Device Class : 2

Duns Number: 081132841

Premarket Exempt : No

Product Code : FZP

Prescription Use : Yes

Device Count : 1

Dextera MicroCutter 5/80 Stapler - 11814900003025 Catalog Number : FG-025302

Device Description : Endoscopic Surgical Stapler

Device Class : 2

Duns Number: 081132841

Premarket Exempt : No

Product Code : GAG

Prescription Use : Yes

Device Count : 1

MicroCutter 30 White Reload - 11814900003100 Catalog Number : FG-025310

Device Description : MicroCutter 30 White Reload is compatible with the MicroCutter 5/80 Stapler

Device Class :

Duns Number: 081132841

Premarket Exempt : No

Product Code : GDW

Prescription Use : Yes

Device Count : 12

MicroCutter 30 Curved Tip White Reload - 11814900003117 Catalog Number : FG-025311

Device Description : MicroCutter 30 Curved Tip White Reload is compatible with the MicroCutter 5/80 Stapler

Device Class :

Duns Number: 081132841

Premarket Exempt : No

Product Code : GDW

Prescription Use : Yes

Device Count : 12

MicroCutter 30 Blue Reload - 11814900003209 Catalog Number : FG-025320

Device Description : MicroCutter 30 Blue Reload is compatible with the MicroCutter 5/80 Stapler

Device Class :

Duns Number: 081132841

Premarket Exempt : No

Product Code : GDW

Prescription Use : Yes

Device Count : 12

MicroCutter 30 Curved Tip Blue Reload - 11814900003216 Catalog Number : FG-025321

Device Description : MicroCutter 30 Curved Tip Blue Reload is compatible with the MicroCutter 5/80 Stapler

Device Class :

Duns Number: 081132841

Premarket Exempt : No

Product Code : GDW

Prescription Use : Yes

Device Count : 12

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