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 BASX - 10705036001522 Catalog Number : CTB5LT

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 - 10705036001539 Catalog Number : CTB5ST

Device Description : Endopath BASX Stability Sleeves

Device Class :

Duns Number: 044606982

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ENDOPATH XCEL - 10705036001560 Catalog Number : D11LT

Device Description : Endopath XCEL Dilating Tip Trocars with Stability Sleeves

Device Class :

Duns Number: 044606982

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ENDOPATH XCEL - 10705036001577 Catalog Number : D12LT

Device Description : Endopath XCEL Dilating Tip Trocars with Stability Sleeves

Device Class :

Duns Number: 044606982

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ENDOPATH XCEL - 10705036001584 Catalog Number : D12XT

Device Description : Endopath XCEL Dilating Tip Trocars with Stability Sleeves

Device Class :

Duns Number: 044606982

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ENDOPATH XCEL - 10705036001591 Catalog Number : D5LT

Device Description : Endopath XCEL Dilating Tip Trocars with Stability Sleeves

Device Class :

Duns Number: 044606982

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ENDOPATH XCEL - 10705036001607 Catalog Number : D5ST

Device Description : Endopath XCEL Dilating Tip Trocars with Stability Sleeves

Device Class :

Duns Number: 044606982

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ECHELON ENDOPATH - 10705036001669 Catalog Number : EC45

Device Description : ECHELON 45 Endoscopic Linear Cutter Straight 340 mm No cartridge

Device Class :

Duns Number: 044606982

Premarket Exempt : No

Product Code : GDW

Prescription Use : Yes

Device Count : 1

ECHELON ENDOPATH - 10705036001676 Catalog Number : EC45A

Device Description : Echelon Flex45 Endopath Stapler, Articulating Endoscopic Linear Cutter (No cartridge)

Device Class :

Duns Number: 044606982

Premarket Exempt : No

Product Code : GDW

Prescription Use : Yes

Device Count : 1

ECHELON ENDOPATH - 10705036001683 Catalog Number : EC45AL

Device Description : Echelon Flex45 Endopath Stapler, Long Articulating Endoscopic Linear Cutter (No cartridge)

Device Class :

Duns Number: 044606982

Premarket Exempt : No

Product Code : GDW

Prescription Use : Yes

Device Count : 1

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