Integra Essential Shunt Kit - HS ESSENTIAL CSF SHUNT SYSTEMThe Integra - Integra Lifesciences Corporation

Duns Number:083171244

Device Description: HS ESSENTIAL CSF SHUNT SYSTEMThe Integra Essential Shunt Kit- Burr Hole Design contains on HS ESSENTIAL CSF SHUNT SYSTEMThe 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.

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More Product Details

Catalog Number

NL8504111

Brand Name

Integra Essential Shunt Kit

Version/Model Number

NL8504111

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K153041,K973525,K153041,K973525

Product Code Details

Product Code

JXG

Product Code Name

Shunt, central nervous system and components

Device Record Status

Public Device Record Key

f10340dc-0857-4f15-8bd2-498c92aabc9b

Public Version Date

October 10, 2022

Public Version Number

3

DI Record Publish Date

March 05, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INTEGRA LIFESCIENCES CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 14
2 A medical device with a moderate to high risk that requires special controls. 75
3 A medical device with high risk that requires premarket approval 17
U Unclassified 32