AccessGUDID - DEVICE: OSV II Valve System (10381780035992)

GUDID

Device Identifier (DI) Information

Brand Name: OSV II Valve System
Version or Model: 9OS1000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 9OS1000
Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

Primary DI Number: 10381780035992
Issuing Agency: GS1
Commercial Distribution End Date: July 03, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 531408342 *Terms of Use

Device Description: The OSV II Hydrocephalus Valve System is an implantable device for controlled cerebrospinal fluid (CSF) drainage from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart's right atrium. Unlike conventional valves, the OSV II Valve System is a varable resistnace valve which maintains a dreanage rate close to the CSF secretion rate (20 ml/hr) within the physioligical range of intracranial of pressure. 2

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
61123	Ventriculo-peritoneal/atrial shunt	An implantable device intended to divert excessive cerebrospinal fluid (CSF) from the brain ventricles to either the peritoneal cavity or the heart right atrium (i.e., dual-capability), where it can be absorbed into the body, as a treatment for increased intracranial pressure (e.g., caused by hydrocephalus). It consists of: 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/atrial catheter that channels the CSF to the peritoneal cavity or right atrium; some types have a port/reservoir for hypodermic sampling/infusion. 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 [?]
Premarket Submission Number Not Available/Not Released

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
Special Storage Condition, Specify: Room temperature

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Flow Regulation Valve: 18-30ml/h, Distal Cath. 110cm Length x 2.3mm O.D. x 1.1mm I.D. (F7), Vent. Cath. 13cm Length x 2.7mm O.D. x 1.4mm I.D. (F8), Right Angle Guide 4.9mm Diam.

Device Record Status

Public Device Record Key: aaf2a4b5-79dc-4448-bfd5-15a804b05b1d
Public Version Date: April 07, 2021
Public Version Number: 4
DI Record Publish Date: October 01, 2015