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Integra Essential Shunt Kit Flat Bottom Design

FDA UDI

Class II (US FDA UDI)

by Integra Lifesciences Corp.

Identity

Trade Name
Integra Essential Shunt Kit Flat Bottom Design FDA UDI
Generic Name
Ventriculoperitoneal shunt FDA UDI
Device Name
The Integra Essential Shunt Kit-Flat Bottom Design is designed to deliver CSF from the ventricles of the brain to the peritoneal cavity. Each kit contains one CSF flushing reservoir with attached 120cm kink-resistant striped peritoneal tubing. The CSF flow control valve is located inside the peritoneal tubing immediately distal to the reservoir. One 18cm ventricular catheter with stylet and one right-angle ventricular catheter guide are also included. FDA UDI
Model / Reference
NL8504120 FDA UDI
Description
The Integra Essential Shunt Kit-Flat Bottom Design is designed to deliver CSF from the ventricles of the brain to the peritoneal cavity. Each kit contains one CSF flushing reservoir with attached 120cm kink-resistant striped peritoneal tubing. The CSF flow control valve is located inside the peritoneal tubing immediately distal to the reservoir. One 18cm ventricular catheter with stylet and one right-angle ventricular catheter guide are also included. FDA UDI

Identifiers

Catalog Number
NL8504120 FDA UDI
Primary DI / UDI-DI
10381780071594 FDA UDI
510(k) Number
K153041 FDA UDI
K973525 FDA UDI
FDA Product Code
JXG FDA UDI
GMDN Term
Ventriculoperitoneal shunt FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5550 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Integra Essential Shunt Kit Flat Bottom Design by Integra Lifesciences Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K153041 also covers:

K973525 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Integra Lifesciences Corp.

Sources (1)

  • FDA UDI 30eb778f-ba38-4cb8-a2a9-40d6ec2397d9 38 fields · synced May 30, 2026