Dual Outlet Convertible Integra™ Reservoir

FDA UDI

Class II (US FDA UDI)

by Integra Lifesciences Corp.

Identity

Trade Name: Dual Outlet Convertible Integra™ Reservoir FDA UDI
Generic Name: Cerebrospinal fluid shunt valve FDA UDI
Device Name: The silicone elastomer Integra CSF Reservoir, in connection with a ventricular catheter, is designed to provide access to the brain and/or CSF. The Convertible model incorporates an outlet tube in addition to an inlet tube. The outlet tube may be connected to a distal catheter, allowing the reservoir to be used in a shunting system, if later indicated. The 2.5cm base diameter reservoir is a flat bottom design; the 1.5cm base diameter reservoir is a burr-hole model. FDA UDI
Model / Reference: NL79034S02 FDA UDI
Description: The silicone elastomer Integra CSF Reservoir, in connection with a ventricular catheter, is designed to provide access to the brain and/or CSF. The Convertible model incorporates an outlet tube in addition to an inlet tube. The outlet tube may be connected to a distal catheter, allowing the reservoir to be used in a shunting system, if later indicated. The 2.5cm base diameter reservoir is a flat bottom design; the 1.5cm base diameter reservoir is a burr-hole model. FDA UDI

Identifiers

Catalog Number: NL79034S02 FDA UDI
Primary DI / UDI-DI: 10381780112273 FDA UDI
FDA Product Code: JXG FDA UDI
GMDN Term: Cerebrospinal fluid shunt valve FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5550 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Cerebrospinal fluid shunt valve

Dual Outlet Convertible Integra™ Reservoir by Integra Lifesciences Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Integra Lifesciences Corp.

Sources (1)

FDA UDI e744a3cf-4e1e-48da-8e5c-48d9591fc683 36 fields · synced Jun 1, 2026