SOPHYSA

Primary DI
03760124130676
Brand
SOPHYSA
Company
SOPHYSA
Model
PSO-3000
Device description
PRESSIO ICP MONITOR
Published
2016-07-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
GWMDEVICE, MONITORING, INTRACRANIAL PRESSURE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWMDevice, Monitoring, Intracranial PressureNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062584000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062584000PRESSIO ICP MONITORING SYSTEMSophysa SA2007-07-05GWM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760124130676PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760124130676037601241306763760124130676

GMDN Terms#

Term, Definition table
TermDefinition
Intracranial pressure monitorAn electrically-powered device intended for intermittent or continuous measurement and display of intracranial pressure (ICP). It is used in conjunction with an invasive intracranial device (e.g., intracerebral sensor catheter) that transmits electrical signals via connected cables or pressure signals via tubing (e.g., via the air pouch method). It may include an alarm designed to alert clinical staff to an elevated ICP and may also produce a strip-chart recording or display of the ICP waveform that enables interpretation of long-term ICP trends.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07908398200008BraincareBRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SAGWM2026-05-08
00850013266272IRRAflow Cranial Access BoltClearpoint Neuro, Inc.GWM2025-07-24
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00763000281229Exacta Pole Clamp with laser levelMEDTRONIC PS MEDICAL, INC.GWM2025-02-16
00763000467401NAMEDTRONIC PS MEDICAL, INC.GWM2024-06-01
00763000406073BeckerMEDTRONIC PS MEDICAL, INC.GWM2024-03-31
20763000467344NAMEDTRONIC PS MEDICAL, INC.GWM2024-03-01
20763000467351NAMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
20763000467382NAMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
20763000467399NAMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
00763000406080NAMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
00763000431259BeckerMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
00763000529307BeckerMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
00763000529369BeckerMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
00763000572877BeckerMEDTRONIC PS MEDICAL, INC.GWM2024-02-25
00850013266203IRRAflow Tube SetClearpoint Neuro, Inc.GWM2023-11-02
00763000624774Duet®MEDTRONIC PS MEDICAL, INC.GWM2022-03-10
00763000624781Duet®MEDTRONIC PS MEDICAL, INC.GWM2022-03-10
00763000624798Duet®MEDTRONIC PS MEDICAL, INC.GWM2022-03-10
00763000428723Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-03-07
00763000428747Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-03-07
00763000428754Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-03-07
00763000428761Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-03-07
00763000428778Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-03-07
00763000431273Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-02-13
20763000431307N/AMEDTRONIC PS MEDICAL, INC.GWM2021-02-07
00763000395971Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-02-07
00763000395988N/AMEDTRONIC PS MEDICAL, INC.GWM2021-02-07
00763000406004Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-02-07
00763000406011Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-02-07