INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Address:11 Cabot Blvd.,Mansfield,MA,02048,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

TRAY, SURGICAL, INSTRUMENT (FSM) (7) CATHETER, VENTRICULAR (HCA) (2) Shunt, central nervous system and components (JXG) (1)

Premarket Exempt

No Yes

Clear

CODMAN® BACTISEAL® - 10381780525509 Catalog Number : NS5115

Device Description : Ventricular Catheter Set Includes: Ventricular Catheter, Stylet, Luer Connector, Ventricular Catheter Set Includes: Ventricular Catheter, Stylet, Luer Connector, Cap, Catheter Anchoring Clip, Right Angle Adapter and Information Manual

Device Class : 2

Duns Number: 081277700

Premarket Exempt : No

Product Code : JXG

Prescription Use : Yes

Device Count : 1

CODMAN® HAKIM® - 10381780526797 Catalog Number : NS5524

Device Description : Shunt System Clear with Barium Stripe Peritoneal Catheter, with Drainage Holes a Shunt System Clear with Barium Stripe Peritoneal Catheter, with Drainage Holes and Markings Includes: Information Manual

Device Class : 2

Duns Number: 081277700

Premarket Exempt : No

Product Code : HCA

Prescription Use : Yes

Device Count : 1

CODMAN® BACTISEAL® - 10381780526803 Catalog Number : NS5525

Device Description : Ventricular Catheter with centimeter markings with BACTISEAL Shunt System. Cont Ventricular Catheter with centimeter markings with BACTISEAL Shunt System. Contents: BACTISEAL Ventricular Catheter (1), Stylet (1), RA Adapter (1), Information manual (1)

Device Class : 2

Duns Number: 081277700

Premarket Exempt : No

Product Code : HCA

Prescription Use : Yes

Device Count : 1

Integra® Jarit® - 10381780527411 Catalog Number : 117-160A

Device Description : Mayo Tray, Perforated, 10"x 6-1/2" x 3/4"

Device Class : 1

Duns Number: 081277700

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

Integra® Jarit® - 10381780527428 Catalog Number : 117-162A

Device Description : Mayo Tray, Perforated, 13-3/4" x 10" x 3/4"

Device Class : 1

Duns Number: 081277700

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

Integra® Jarit® - 10381780527435 Catalog Number : 117-164A

Device Description : Mayo Tray, Perforated, 15-1/4" x 10-5/8" x 3/4"

Device Class : 1

Duns Number: 081277700

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

Integra® Jarit® - 10381780527442 Catalog Number : 117-166A

Device Description : Mayo Tray, Perforated, 17"x 11-3/4" x 3/4"

Device Class : 1

Duns Number: 081277700

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

Integra® Jarit® - 10381780527459 Catalog Number : 117-168A

Device Description : Mayo Tray, Perforated, 19-1/4" x 12-3/4" x 3/4"

Device Class : 1

Duns Number: 081277700

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

Integra® Jarit® - 10381780527466 Catalog Number : 117-190A

Device Description : Deep Perforated Instrument Tray, 8-3/4" x 5" x 1-3/4"

Device Class : 1

Duns Number: 081277700

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

Integra® Jarit® - 10381780527473 Catalog Number : 117-192A

Device Description : Deep Perforated Instrument Tray, 10-3/8" x 6-3/4" x 1-7/8"

Device Class : 1

Duns Number: 081277700

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

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