ETHICON ENDO-SURGERY, LLC

Address:475 CALLE C,GUAYNABO,PR,00969,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

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES (GEI) (5) STAPLE, IMPLANTABLE (GDW) (4) Applier, surgical, clip (GDO) (1)

Premarket Exempt

No Yes

Clear

LIGACLIP - 20705036012921 Catalog Number : LX230

Device Description : Ligaclip Clip Applier Medium Right Angle 26.7cm

Device Class :

Duns Number: 044606982

Premarket Exempt : Yes

Product Code : GDO

Prescription Use : Yes

Device Count : 1

ENDOPATH - 20705036013355 Catalog Number : TSB35

Device Description : Endopath ETS- Endoscopic Linear Cutter, 35mm

Device Class :

Duns Number: 044606982

Premarket Exempt : No

Product Code : GDW

Prescription Use : Yes

Device Count : 3

ENDOPATH - 20705036013362 Catalog Number : TSW35

Device Description : Endopath ETS- Endoscopic Linear Cutter, 35mm

Device Class :

Duns Number: 044606982

Premarket Exempt : No

Product Code : GDW

Prescription Use : Yes

Device Count : 3

ENDOPATH - 20705036013850 Catalog Number : EBC05

Device Description : Endopath Bipolar Active/Return Cord with Fixed Pin Connector 1.12 inch (28.5mm)

Device Class : 2

Duns Number: 044606982

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

ENSEAL - 20705036013881 Catalog Number : EGA11

Device Description : ENSEAL Generator Connector

Device Class : 2

Duns Number: 044606982

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

N/A - 20705036013898 Catalog Number : FSW11

Device Description : Foot Switch G11

Device Class : 2

Duns Number: 044606982

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

N/A - 20705036013904 Catalog Number : CRT11

Device Description : Cart G11

Device Class : 2

Duns Number: 044606982

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

ValuTrus - 20705036013911 Catalog Number : ADPH

Device Description : ValuTrus Reusable PPH Circular Stapler Handle

Device Class : 2

Duns Number: 044606982

Premarket Exempt : No

Product Code : GDW

Prescription Use : Yes

Device Count : 1

N/A - 20705036013959 Catalog Number : GEN11

Device Description : Generator G11

Device Class : 2

Duns Number: 044606982

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

ValuTrus - 20705036013980 Catalog Number : ADLH

Device Description : ValuTrus Reusable Linear Stapler Handle, Reusable

Device Class : 2

Duns Number: 044606982

Premarket Exempt : No

Product Code : GDW

Prescription Use : Yes

Device Count : 1

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