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Integra Essential Shunt Kit

FDA UDI

Class II (US FDA UDI)

by Integra Lifesciences Corp.

Identity

Trade Name
Integra Essential Shunt Kit FDA UDI
Generic Name
Ventriculoperitoneal shunt FDA UDI
Device Name
HS ESSENTIAL CSF SHUNT SYSTEM The Integra Essential Shunt Kit- Burr Hole Design contains one 16mm CSF Flow Control Valve, one 18cm Ventricular Catheter with stylet and one 120cm open-ended peritoneal catheter. The CSF flow control valve, designed for placement in a formal burr hole, is a spherically shaped, silicone elastomer device used for the treatment of hydrocephalic patients when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. The valve incorporates an internal medium pressure diaphragm for proximal control of CSF flow. The device also provides one-way flow control. The kit is designed to deliver CSF from the ventricles of the brain to the peritoneal cavity. FDA UDI
Model / Reference
NL8504111 FDA UDI
Description
HS ESSENTIAL CSF SHUNT SYSTEM The Integra Essential Shunt Kit- Burr Hole Design contains one 16mm CSF Flow Control Valve, one 18cm Ventricular Catheter with stylet and one 120cm open-ended peritoneal catheter. The CSF flow control valve, designed for placement in a formal burr hole, is a spherically shaped, silicone elastomer device used for the treatment of hydrocephalic patients when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. The valve incorporates an internal medium pressure diaphragm for proximal control of CSF flow. The device also provides one-way flow control. The kit is designed to deliver CSF from the ventricles of the brain to the peritoneal cavity. FDA UDI

Identifiers

Catalog Number
NL8504111 FDA UDI
Primary DI / UDI-DI
10381780071570 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 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 ca30fda1-7336-4895-9e92-3eb82dcb170e 38 fields · synced May 30, 2026