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

STAPLE, IMPLANTABLE (GDW) (9) ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES (GEI) (1)

Premarket Exempt

Yes No

Clear

Harmonic - 20705036013997 Catalog Number : HGA11

Device Description : Harmonic Generator Connector

Device Class : 2

Duns Number: 044606982

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

NA - 20705036014055 Catalog Number : CCS25

Device Description : Disposable Curved Circular Stapler

Device Class : 2

Duns Number: 044606982

Premarket Exempt : No

Product Code : GDW

Prescription Use : Yes

Device Count : 1

NA - 20705036014062 Catalog Number : CCS29

Device Description : Disposable Curved Circular Stapler

Device Class : 2

Duns Number: 044606982

Premarket Exempt : No

Product Code : GDW

Prescription Use : Yes

Device Count : 1

ValuTrus - 20705036014222 Catalog Number : ADL40R

Device Description : ValuTrus Reusable Linear Stapler Reload, 40mm, Disposable

Device Class :

Duns Number: 044606982

Premarket Exempt : No

Product Code : GDW

Prescription Use : Yes

Device Count : 12

ECHELON ENDOPATH - 20705036014369 Catalog Number : ECR60T

Device Description : Endoscopic Linear Cutter Reloads Black 4.4mm, 6 rows

Device Class :

Duns Number: 044606982

Premarket Exempt : No

Product Code : GDW

Prescription Use : Yes

Device Count : 12

ValuTrus - 20705036014420 Catalog Number : ADP325R

Device Description : ValuTrus PPH Circular Stapler Reload & Accessory Set, 32.5 mm, Disposable

Device Class :

Duns Number: 044606982

Premarket Exempt : No

Product Code : GDW

Prescription Use : Yes

Device Count : 3

ValuTrus - 20705036014529 Catalog Number : ADCH

Device Description : ValuTrus Reusable Circular Stapler Handle

Device Class : 2

Duns Number: 044606982

Premarket Exempt : No

Product Code : GDW

Prescription Use : Yes

Device Count : 1

ValuTrus - 20705036014536 Catalog Number : ADC285R

Device Description : ValuTrus Circular Stapler Reload, 28.5mm, Disposable

Device Class :

Duns Number: 044606982

Premarket Exempt : No

Product Code : GDW

Prescription Use : Yes

Device Count : 6

ValuTrus - 20705036014543 Catalog Number : ADC325R

Device Description : ValuTrus Circular Stapler Reload, 32.5mm, Disposable

Device Class :

Duns Number: 044606982

Premarket Exempt : No

Product Code : GDW

Prescription Use : Yes

Device Count : 6

ValuTrus - 20705036014642 Catalog Number : ADC255R

Device Description : Circular Stapler Reload, 25.5mm, Disposable

Device Class :

Duns Number: 044606982

Premarket Exempt : No

Product Code : GDW

Prescription Use : Yes

Device Count : 6

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