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

Device, monitoring, intracranial pressure (GWM) (3) Agent, Absorbable Hemostatic, Collagen Based (LMF) (2) Electrosurgical, cutting & coagulation & accessories (GEI) (2) Shunt, central nervous system and components (JXG) (1)

Premarket Exempt

No Yes

Clear

CERTAS™ - 10381780532897 Catalog Number : 82-8852

Device Description : The CERTAS Tool Kit consists of five components:• Adjustable Height Locator Tool The CERTAS Tool Kit consists of five components:• Adjustable Height Locator Tool• Low Profile Locator Tool• Indicator Tool• Adjustment Tool• X-Ray Overlay Tool

Device Class : 2

Duns Number: 081277700

Premarket Exempt : No

Product Code : JXG

Prescription Use : Yes

Device Count : 1

CereLink® - 10381780533764 Catalog Number : 82-6822

Device Description : ICP Replacement Power Supply

Device Class : 2

Duns Number: 081277700

Premarket Exempt : No

Product Code : GWM

Prescription Use : Yes

Device Count : 1

CereLink® - 10381780533771 Catalog Number : 82-6824

Device Description : ICP Replacement Battery

Device Class : 2

Duns Number: 081277700

Premarket Exempt : No

Product Code : GWM

Prescription Use : Yes

Device Count : 1

CereLink® - 10381780533788 Catalog Number : 826820

Device Description : ICP Monitor

Device Class : 2

Duns Number: 081277700

Premarket Exempt : No

Product Code : GWM

Prescription Use : Yes

Device Count : 1

Codman® - 10381780533825 Catalog Number : 901001CBL1

Device Description : Electrosurgical Interconnecting Cable

Device Class : 2

Duns Number: 081277700

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Codman® - 10381780533832 Catalog Number : 901001CBL2

Device Description : Electrosurgical Interconnecting Cable for CMC®-V

Device Class : 2

Duns Number: 081277700

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

INSTAT* MCH Microfibrillar Collagen Hemostat - 10705031003194 Catalog Number : 1984

Device Description : ABSORBABLE COLLAGEN HEMOSTATIC AGENT FIBRILLAR FORM, 0.5GRAM

Device Class : 3

Duns Number: 081277700

Premarket Exempt : No

Product Code : LMF

Prescription Use : Yes

Device Count : 1

INSTAT* MCH Microfibrillar Collagen Hemostat - 10705031003217 Catalog Number : 1985

Device Description : ABSORBABLE COLLAGEN HEMOSTATIC AGENT FIBRILLAR FORM, 1GRAM

Device Class : 3

Duns Number: 081277700

Premarket Exempt : No

Product Code : LMF

Prescription Use : Yes

Device Count : 1

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