AccessGUDID - DEVICE: Integra LPV II Valve Shunt Kit (10381780072485)

GUDID

Device Identifier (DI) Information

Brand Name: Integra LPV II Valve Shunt Kit
Version or Model: NL8509850
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NL8509850
Company Name: Integra Lifesciences Corporation

Primary DI Number: 10381780072485
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083171244 *Terms of Use

Device Description: STANDARD LPV II SHUNT KIT, MED. The Integra LPV II Valve Shunt Kits are designed to deliver CSF from the ventricles of the brain to the peritoneal cavity. The kit contains a LPV II valve, standard, a Pudenz Ventricular Catheter and an integral, open-ended kink resistant catheter attached to the outlet of the valve. The kit is available in a medium pressure range. All valves and catheters contain barium sulfate for x-ray detectability.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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":	No
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
K974708	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: Valve Length: 36.7mm, Valve Width: 16.7mm, Profile Height: 7.8mm

Device Record Status

Public Device Record Key: 3a413274-c676-43a5-9530-768aadd7da07
Public Version Date: October 10, 2022
Public Version Number: 6
DI Record Publish Date: September 22, 2015