Integra Multi-Purpose Valve

Primary DI
10381780071228
Brand
Integra Multi-Purpose Valve
Company
Integra Lifesciences Corporation
Model
NL8500105
Catalog number
NL8500105
Device description
VALVE MULTI-PURPOSE The silicone elastomer Multi-Purpose Valve is a system designed to facilitate the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. This system is composed of an occluder, a flushing reservoir, a miter valve, an on-off control, and an anti-siphon device. CSF from the ventricular catheter flows through the inlet tube and the occluder into the flushing reservoir, through the miter valve and anti-siphon device, then out the distal catheter. The flat-bottom design of the Multi-Purpose Valve eliminates the need for a formal burr hole, provides greater latitude in positioning the device, and allows the ventricular catheter to be revised without disturbing the flushing valve. This valve is provided in a low pressure.
Published
2016-12-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JXGShunt, central nervous system and components

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXGShunt, Central Nervous System And ComponentsNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780071228PrimaryGS10
M269NL85001051SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178007122810381780071228

GMDN Terms#

Term, Definition table
TermDefinition
Ventriculo-peritoneal/atrial shunt valveA sterile implantable device intended to function as part of a ventriculoperitoneal or ventriculoatrial shunt to regulate the pressure and flow level of cerebrospinal fluid (CSF) from the brain to the peritoneum/heart right atrium in the management of increased intracranial pressure (e.g., caused by hydrocephalus). It consists of a mechanical valve with catheter connections and is made of plastic and silicone materials. It typically opens at a pre-set pressure and may be non-invasively adjusted using a dedicated programmer.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
083171244
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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