AccessGUDID - DEVICE: Integra Essential Shunt Kit (10381780071587)

GUDID

Device Identifier (DI) Information

Brand Name: Integra Essential Shunt Kit
Version or Model: NL8504112
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: NL8504112
Company Name: Integra Lifesciences Corporation

Primary DI Number: 10381780071587
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 083171244 *Terms of Use

Device 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 high 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.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45694	Ventriculoperitoneal shunt	An implantable device intended to divert excessive cerebrospinal fluid (CSF) from the brain ventricles to the peritoneal cavity, where it can be absorbed into the body, as a treatment for increased intracranial pressure (e.g., caused by hydrocephalus). It typically consists of three main connected parts: 1) an intracerebral ventricular catheter through which CSF flows; 2) a mechanical shunt valve that typically opens at a pre-set pressure; and 3) a peritoneal catheter that channels the CSF to the peritoneal cavity. It is made of plastic and silicone materials; disposable devices associated with implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JXG	Shunt, central nervous system and components

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K153041	000
K973525	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 16mm CSF Flow Control Valve. 18cm ventricular catheter with stylet. 120cm open-ended peritoneal catheter.

Device Record Status

Public Device Record Key: c2f23b06-0a31-4cf5-b6fb-a5a01022c92c
Public Version Date: October 10, 2022
Public Version Number: 7
DI Record Publish Date: September 22, 2015