FDA.reportPublic FDA data

Sophysa

Primary DI
03760124131932
Brand
Sophysa
Company
SOPHYSA
Model
SAK-LI1
Device description
SOPHY MINI SM8 LOCATING INSTRUMENT
Published
2015-10-16
Public version status
Update
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
K013488000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013488000SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8Sophysa SA2002-03-27JXG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760124131932PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760124131932037601241319323760124131932

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.

Regulatory Flags#

DUNS number
262951353
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760124131758SophysaPSO-PBT2017-07-25
03760124131765SophysaPSO-PTT2017-07-25
03760409440285SophysaDE-1042026-06-22
03760409440308SophysaDE-1062026-06-22
03760409440315SophysaDE-1082026-06-22
03760409440322SophysaDE-1092026-06-22
03760409447055SOPHYSAPSO-VT2026-06-08
03760409447093SOPHYSAPSO-VTT2026-06-08
03760124138092SophysaSP032026-06-05
03760124138108SophysaSP042026-06-05
03760124138115SophysaSP052026-06-05
03760409441121SophysaSM1-H2026-06-05
03760409441138SophysaSM1-M2026-06-05
03760409441145SophysaSM1-L2026-06-05
03760409441152SophysaSM1-2010H2026-06-05
03760409441169SophysaSM1-2010M2026-06-05
03760409441176SophysaSM1-2010L2026-06-05
03760409441183SophysaSM1A-H2026-06-05
03760409441190SophysaSM1A-M2026-06-05
03760409441206SophysaSM1A-L2026-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760409440285SophysaSOPHYSAJXG2026-06-22
03760409440308SophysaSOPHYSAJXG2026-06-22
03760409440315SophysaSOPHYSAJXG2026-06-22
03760409440322SophysaSOPHYSAJXG2026-06-22
03760409441121SophysaSOPHYSAJXG2026-06-05
03760409441138SophysaSOPHYSAJXG2026-06-05
03760409441145SophysaSOPHYSAJXG2026-06-05
03760409441152SophysaSOPHYSAJXG2026-06-05
03760409441169SophysaSOPHYSAJXG2026-06-05
03760409441176SophysaSOPHYSAJXG2026-06-05
03760409441183SophysaSOPHYSAJXG2026-06-05
03760409441190SophysaSOPHYSAJXG2026-06-05
03760409441206SophysaSOPHYSAJXG2026-06-05
03760409441213SophysaSOPHYSAJXG2026-06-05
03760409441220SophysaSOPHYSAJXG2026-06-05
03760409441237SophysaSOPHYSAJXG2026-06-05
03760409441244SophysaSOPHYSAJXG2026-06-05
03760409441251SophysaSOPHYSAJXG2026-06-05
03760409441268SophysaSOPHYSAJXG2026-06-05
10381780535362CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535379CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535393CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlJXG2024-11-20
10381780535430CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlJXG2024-11-20
20763000467382NAMEDTRONIC PS MEDICAL, INC.JXG2024-02-26
00763000406080NAMEDTRONIC PS MEDICAL, INC.JXG2024-02-26
10381780533900CODMAN® HAKIM®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2023-07-13
10381780534006CODMAN® HAKIM®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2023-07-13
10381780534013CODMAN® HAKIM®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2023-07-13
10381780534020CODMAN® HAKIM®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2023-07-13
10381780534037CODMAN® HAKIM®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2023-07-13