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) (5) ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES (GEI) (2) INSTRUMENT, MANUAL, SURGICAL, GENERAL USE (MDM) (2) STAPLE, IMPLANTABLE (GDW) (1)

Premarket Exempt

No Yes

Clear

ENDOPATH - 10705036000396 Catalog Number : 23NBL

Device Description : Endopath Bladeless Trocars with Smooth Sleeves

Device Class :

Duns Number: 044606982

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ENDOPATH - 10705036000402 Catalog Number : 23NBS

Device Description : Endopath Bladeless Trocars with Smooth Sleeves

Device Class :

Duns Number: 044606982

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

N/A - 10705036000471 Catalog Number : 355NS

Device Description : Non-Shielded Surgical Trocars with Threaded Sleeves

Device Class :

Duns Number: 044606982

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ENDOPATH - 10705036000518 Catalog Number : 35LNA

Device Description : Endopath Bladeless Trocar Obturators and Housing Assemblies for the Endopath Res Endopath Bladeless Trocar Obturators and Housing Assemblies for the Endopath Resposable Trocar System

Device Class :

Duns Number: 044606982

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

N/A - 10705036000525 Catalog Number : 35LNS

Device Description : Non-Shielded Surgical Trocars with Threaded Sleeves

Device Class :

Duns Number: 044606982

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ENDOPATH - 10705036000761 Catalog Number : 5BB

Device Description : 5 mm Babcocks with Ratchet Handles

Device Class :

Duns Number: 044606982

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

ENDOPATH - 10705036000778 Catalog Number : 5DCD

Device Description : 5 mm Curved Dissectors with Monopolar Cautery

Device Class :

Duns Number: 044606982

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

ENDOPATH - 10705036000785 Catalog Number : 5DCS

Device Description : Endopath 5mm Curved Scissors with Monopolar Cautery

Device Class :

Duns Number: 044606982

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

ENDOPATH - 10705036000792 Catalog Number : 5DSG

Device Description : Endopath 5 mm Graspers with Ratchet Handles

Device Class :

Duns Number: 044606982

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

ENDOPATH - 10705036000846 Catalog Number : 6R45B

Device Description : ETS45 Reload Standard 45MM

Device Class :

Duns Number: 044606982

Premarket Exempt : No

Product Code : GDW

Prescription Use : Yes

Device Count : 1

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