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

Laparoscope, general & plastic surgery (GCJ) (7) STAPLE, IMPLANTABLE (GDW) (3)

Premarket Exempt

No Yes

Clear

ENDOPATH XCEL - 10705036001256 Catalog Number : B8LT

Device Description : Endopath XCEL Bladeless Trocars with Stability Sleeves

Device Class :

Duns Number: 044606982

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ENDOPATH XCEL - 10705036001324 Catalog Number : CB11LT

Device Description : ENDOPATH XCEL Universal Trocar Stablility Sleeves

Device Class :

Duns Number: 044606982

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ENDOPATH XCEL - 10705036001331 Catalog Number : CB12LT

Device Description : ENDOPATH XCEL Universal Trocar Stablility Sleeves

Device Class :

Duns Number: 044606982

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ENDOPATH XCEL - 10705036001348 Catalog Number : CB5LT

Device Description : ENDOPATH XCEL Universal Trocar Stablility Sleeves

Device Class :

Duns Number: 044606982

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ENDOPATH XCEL - 10705036001355 Catalog Number : CB5ST

Device Description : ENDOPATH XCEL Universal Trocar Stablility Sleeves

Device Class :

Duns Number: 044606982

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

CONTOUR TRANSTAR - 10705036001416 Catalog Number : CR30G

Device Description : CONTOUR TRANSTAR Curved Cutter Supler Reloads

Device Class :

Duns Number: 044606982

Premarket Exempt : No

Product Code : GDW

Prescription Use : Yes

Device Count : 1

CONTOUR - 10705036001423 Catalog Number : CR40B

Device Description : Contour Curved Cutter Stapler Reload

Device Class :

Duns Number: 044606982

Premarket Exempt : No

Product Code : GDW

Prescription Use : Yes

Device Count : 1

CONTOUR - 10705036001430 Catalog Number : CR40G

Device Description : Contour Curved Cutter Stapler Reload

Device Class :

Duns Number: 044606982

Premarket Exempt : No

Product Code : GDW

Prescription Use : Yes

Device Count : 1

ENDOPATH BASX - 10705036001508 Catalog Number : CTB11LT

Device Description : Endopath BASX Stability Sleeves

Device Class :

Duns Number: 044606982

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ENDOPATH BASX - 10705036001515 Catalog Number : CTB12LT

Device Description : Endopath BASX Stability Sleeves

Device Class :

Duns Number: 044606982

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

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