Integra LifeSciences Switzerland Sàrl

Address:Rue Girardet 29,Le Locle Neuchatel,CH

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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

Shunt, central nervous system and components (JXG) (10)

Premarket Exempt

No Yes

Clear

CODMAN CERTAS® SIPHONGUARD® BACTISEAL® - 10381780529293 Catalog Number : 82-8827PL

Device Description : Programmable Valve Right Angle Valve with SIPHONGUARD, Accessories and UnitizedC Programmable Valve Right Angle Valve with SIPHONGUARD, Accessories and UnitizedCatheter Includes:Ventricular Catheter,Unitized Distal Catheter, Priming Adapter and Information Manual

Device Class : 2

Duns Number: 480186617

Premarket Exempt : No

Product Code : JXG

Prescription Use : Yes

Device Count : 1

CODMAN CERTAS® - 10381780529316 Catalog Number : 82-8810PL

Device Description : Programmable Valve Inline Small Valve Only Includes: Priming Adapter and Informa Programmable Valve Inline Small Valve Only Includes: Priming Adapter and Information Manual

Device Class : 2

Duns Number: 480186617

Premarket Exempt : No

Product Code : JXG

Prescription Use : Yes

Device Count : 1

CODMAN CERTAS® - 10381780529330 Catalog Number : 82-8811PL

Device Description : Programmable Valve Inline Small Valve with Accessories Includes: Ventricular Cat Programmable Valve Inline Small Valve with Accessories Includes: Ventricular Catheter, Separable Distal Catheter, Priming Adapter, Right Angle Adapter and Information Manual

Device Class : 2

Duns Number: 480186617

Premarket Exempt : No

Product Code : JXG

Prescription Use : Yes

Device Count : 1

CODMAN CERTAS® - 10381780529354 Catalog Number : 82-8812PL

Device Description : Programmable Valve Inline Small Valve with Accessories and Unitized Catheter Inc Programmable Valve Inline Small Valve with Accessories and Unitized Catheter Includes: Ventricular Catheter, Unitized Distal Catheter, Priming Adapter, Right Angle Adapter and Information Manual

Device Class : 2

Duns Number: 480186617

Premarket Exempt : No

Product Code : JXG

Prescription Use : Yes

Device Count : 1

CODMAN CERTAS® SIPHONGUARD® - 10381780529378 Catalog Number : 82-8814PL

Device Description : Programmable Valve Inline Small Valve Only withIncludes: Priming Adapter and Inf Programmable Valve Inline Small Valve Only withIncludes: Priming Adapter and Information Manual

Device Class : 2

Duns Number: 480186617

Premarket Exempt : No

Product Code : JXG

Prescription Use : Yes

Device Count : 1

CODMAN CERTAS® SIPHONGUARD® - 10381780529392 Catalog Number : 82-8815PL

Device Description : Programmable Valve Inline Small Valve withand Accessories Includes: Ventricular Programmable Valve Inline Small Valve withand Accessories Includes: Ventricular Catheter, Separable Distal Catheter, Priming Adapter, Right Angle Adapter and Information Manual

Device Class : 2

Duns Number: 480186617

Premarket Exempt : No

Product Code : JXG

Prescription Use : Yes

Device Count : 1

CODMAN CERTAS® SIPHONGUARD® - 10381780529415 Catalog Number : 82-8816PL

Device Description : Programmable Valve Inline Small Valve with SIPHONGUARD, Accessories and Unitized Programmable Valve Inline Small Valve with SIPHONGUARD, Accessories and Unitized Catheter Includes: Ventricular Catheter, Unitized Distal Catheter, Priming Adapter, Right Angle Adapter and Information Manual

Device Class : 2

Duns Number: 480186617

Premarket Exempt : No

Product Code : JXG

Prescription Use : Yes

Device Count : 1

CERTAS® Plus - 10381780529439 Catalog Number : 82-8820PL

Device Description : Programmable Valve Right Angle Valve Only Includes: Priming Adapter and Information Manual

Device Class : 2

Duns Number: 480186617

Premarket Exempt : No

Product Code : JXG

Prescription Use : Yes

Device Count : 1

CODMAN CERTAS® Plus - 10381780529453 Catalog Number : 82-8821PL

Device Description : Programmable Valve Right Angle Valve with Accessories Includes: Ventricular Cath Programmable Valve Right Angle Valve with Accessories Includes: Ventricular Catheter, Separable Distal Catheter, Priming Adapter and Information Manual

Device Class : 2

Duns Number: 480186617

Premarket Exempt : No

Product Code : JXG

Prescription Use : Yes

Device Count : 1

CODMAN CERTAS® Plus - 10381780529477 Catalog Number : 82-8822PL

Device Description : Programmable Valve Right Angle Valve with Accessories and Unitized Catheter Incl Programmable Valve Right Angle Valve with Accessories and Unitized Catheter Includes: Ventricular Catheter, Unitized Distal Catheter, Priming Adapter and Information Manual

Device Class : 2

Duns Number: 480186617

Premarket Exempt : No

Product Code : JXG

Prescription Use : Yes

Device Count : 1

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