FDA.report

OSV II Valve System

Primary DI
10381780035992
Brand
OSV II Valve System
Company
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
Model
9OS1000
Catalog number
9OS1000
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
Published
2015-10-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
JXGShunt, central nervous system and components

Product Code Classifications

CodeDeviceSpecialtyClass
JXGShunt, Central Nervous System And ComponentsNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10381780035992PrimaryGS10
M2729OS10001SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1038178003599210381780035992

GMDN Terms

TermDefinition
Ventriculo-peritoneal/atrial shuntAn 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.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Room temperature

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags

DUNS number
531408342
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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10381780034582CSF Reservoir9993019993012015-10-01
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10381780034605CSF Reservoir9993039993032015-10-01
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M27217185C121Integra®17185C122016-08-12
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M27217185C321Integra®17185C322016-08-12
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M27217185C641Integra®17185C642016-08-12
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M27240M431Auragen™40M432016-08-08
M27240M451Auragen™40M452016-08-08
M27240M461Auragen™40M462016-08-08
M27240M471Auragen™40M472016-08-08

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