FDA.reportPublic FDA data

Phoenix Neuro

Primary DI
03760124134506
Brand
Phoenix Neuro
Company
SOPHYSA
Model
NNTA30
Device description
Mini Perf Unitized Tapping Reservoir, AB ventricular catheter, 3 cm
Published
2015-10-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Sterile
true
Single use
true

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
K021644000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021644000PERF (OMMAYA STYLE) RESERVOIRSPhoenix Biomedical Corp.2002-08-06JXG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760124134506PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760124134506037601241345063760124134506

GMDN Terms#

Term, Definition table
TermDefinition
Cerebrospinal fluid shunt port/reservoirAn implantable component of a lumboperitoneal, ventriculoperitoneal or ventriculoatrial shunt designed to be connected to a lumbar, ventricular and/or peritoneal catheter (not included) to permit hypodermic infusion/injection of materials (e.g., chemotherapeutic agents, radioisotopes) into the central nervous system via the subarachnoid lumbar or cerebral space, in the management of raised cerebrospinal fluid (CSF) pressure (e.g., caused by hydrocephalus); it may also be used for drainage of CSF. It consists of a plastic puncturable dome with catheter connections; it does not include a valve.

Sterilization Methods#

Method table
Method

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
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
03760409441213SophysaSM1A-2010H2026-06-05
03760409441220SophysaSM1A-2010M2026-06-05
03760409441237SophysaSM1A-2010L2026-06-05
03760409441244SophysaSM1B-H2026-06-05
03760409441251SophysaSM1B-M2026-06-05
03760409441268SophysaSM1B-L2026-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10381780535881CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535928CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
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
10381780535867CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlJXG2024-11-20
10381780536734CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780536741CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780536758CODMAN® ACCU-FLO®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780536765CODMAN® ACCU-FLO®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780536789CODMAN® ACCU-FLO®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780536819CODMAN® ACCU-FLO®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29