FDA.reportPublic FDA data

Polaris valves electronic reading instrument

Primary DI
03760124132199
Brand
Polaris valves electronic reading instrument
Company
SOPHYSA
Model
PAK3-ERI
Published
2023-04-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222422000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222422000Polaris Valve Electronic Reading InstrumentSophysa2023-02-02JXG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760124132199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760124132199037601241321993760124132199

GMDN Terms#

Term, Definition table
TermDefinition
Cerebrospinal fluid shunt valve programmerA device intended to noninvasively modify the operating pressure of a programmable, non-active, implanted hydrocephalic valve that will be part of a hydrocephalic shunt system. It is used in neurosurgery for intra- and postoperative treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. It typically includes electronic circuits, a control panel, a programming information display, and transmitter/identification devices (e.g., smart cards). When externally placed on the location of the implanted valve, it is actuated to supply coded magnetic signals to affect mechanical changes to the pressure characteristics of the proprietary implanted valve.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
262951353
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760124131703SophysaSPV-SX2015-10-16
03760409446294Phoenix NeuroFVPC42025-12-24
03760124134315Phoenix NeuroFVPC42015-10-16
03760124132908SophysaPSO-PBT2024-03-26
03760124132915SophysaPSO-PTT2024-03-26
03760124132922SophysaPSO-VTT2024-03-26
03760124131451SophysaTUG-652023-06-02
03760124133813Phoenix NeuroSP052015-10-16
03760124134803Phoenix NeuroSP032015-10-16
03760124134810Phoenix NeuroSP042015-10-16
03760124131444SophysaTUG-452023-06-02
13760124131458SophysaTUG-652023-06-02
03760124131468SophysaTUN-452023-06-02
03760124131475SophysaTUN-652023-06-02
03760124130744SOPHYSAPSO-MC062016-07-20
03760124130751SOPHYSAPSO-MC072016-07-20
03760124131635SOPHYSAPSO-MC102016-07-20
03760124132106SophysaPAK24-SI2017-03-30
03760124130577SophysaPRO92015-10-16
03760124130584SophysaPRO102015-10-16

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Primary DI, Brand, Company table
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10381780535942CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535393CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlJXG2024-11-20
10381780535430CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlJXG2024-11-20
10381780535829CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlJXG2024-11-20
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