ETHICON INC.

Address:ROUTE 22 WEST, P.O. Box 151,Somerville,NJ,08876,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

CATHETER AND TIP, SUCTION (JOL) (4) CATHETER, IRRIGATION (GBX) (3) SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID (GAM) (3)

Premarket Exempt

No Yes

Clear

E-PACK - 10705031002746 Catalog Number : 1851E

Device Description : E-Pack Procedure Kit

Device Class : 2

Duns Number: 002144145

Premarket Exempt : No

Product Code : GAM

Prescription Use : Yes

Device Count : 1

E-PACK - 10705031003002 Catalog Number : 1950E

Device Description : E-Pack Procedure Kit

Device Class : 2

Duns Number: 002144145

Premarket Exempt : No

Product Code : GAM

Prescription Use : Yes

Device Count : 1

J-VAC - 10705031003293 Catalog Number : 2160

Device Description : Bulb Suction Reservoir 100 cc with Anti-Reflux Valve

Device Class : 2

Duns Number: 002144145

Premarket Exempt : Yes

Product Code : JOL

Prescription Use : Yes

Device Count : 1

J-VAC - 10705031003309 Catalog Number : 2161

Device Description : Suction Reservoir 150 mL with "Y" Connector and Anti-Reflux Valve

Device Class : 2

Duns Number: 002144145

Premarket Exempt : Yes

Product Code : JOL

Prescription Use : Yes

Device Count : 1

J-VAC - 10705031003316 Catalog Number : 2162

Device Description : Suction Reservoir 450 mL with "Y" Connector and Anti-Reflux Valve

Device Class :

Duns Number: 002144145

Premarket Exempt : Yes

Product Code : JOL

Prescription Use : Yes

Device Count : 1

J-VAC - 10705031003323 Catalog Number : 2163

Device Description : Suction Reservoir 300 mL with "Y" Connector and Anti-Reflux Valve

Device Class : 2

Duns Number: 002144145

Premarket Exempt : Yes

Product Code : JOL

Prescription Use : Yes

Device Count : 1

E-PACK - 10705031003415 Catalog Number : 2190E

Device Description : E-Pack Procedure Kit

Device Class : 2

Duns Number: 002144145

Premarket Exempt : No

Product Code : GAM

Prescription Use : Yes

Device Count : 1

J-VAC - 10705031003422 Catalog Number : 2199

Device Description : Drain Adapter For Use with J-VAC Closed Wound Drainage System 1/4 inch

Device Class : 1

Duns Number: 002144145

Premarket Exempt : Yes

Product Code : GBX

Prescription Use : Yes

Device Count : 1

BLAKE - 10705031003460 Catalog Number : 2210

Device Description : Blake Silicone Drain, 7 mm flat, 3/4 fluted

Device Class : 1

Duns Number: 002144145

Premarket Exempt : Yes

Product Code : GBX

Prescription Use : Yes

Device Count : 1

BLAKE - 10705031003477 Catalog Number : 2211

Device Description : Blake Silicone Drain, 7 mm flat, full fluted

Device Class : 1

Duns Number: 002144145

Premarket Exempt : Yes

Product Code : GBX

Prescription Use : Yes

Device Count : 1

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