Home GUDID 03760124132915 Sophysa
Primary DI 03760124132915
Brand Sophysa
Company SOPHYSA
Model PSO-PTT
Device description PRESSIO ICP & ICT MONITORING KIT, PARENCHYMAL TUNNELING
Published 2024-03-26
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name GWM DEVICE, MONITORING, INTRACRANIAL PRESSURE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GWM Device, Monitoring, Intracranial Pressure Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 03760124132915 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 03760124132915 03760124132915 3760124132915
GMDN Terms# Term, Definition table Term Definition Intracerebral sensor catheter, short-term A flexible tube with a sensor at the distal end intended to be surgically inserted through the skull for short-term (= 30 days) access to the ventricular and/or parenchymal areas of the brain to measure intracranial parameters [e.g., intracranial pressure (ICP), temperature, partial pressure of oxygen (pO2)]; it may in addition be intended for cerebrospinal fluid (CSF) drainage and/or infusion of materials (e.g., chemotherapeutic agents, radioisotopes). It may include accessory devices intended to facilitate catheter introduction, stabilization, and/or fluid collection/infusion (e.g., stylet, bolts, drills, drainage/infusion port/reservoir). This is a single-use device.
Regulatory Flags# DUNS number 262951353 Device count 1 Serial number true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 03760409447055 SOPHYSA SOPHYSA GWM 2026-06-08 03760409447093 SOPHYSA SOPHYSA GWM 2026-06-08 07908398200008 Braincare BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SA GWM 2026-05-08 00850013266272 IRRAflow Cranial Access Bolt Clearpoint Neuro, Inc. GWM 2025-07-24 00763000281243 Exacta Pole Clamp with laser level MEDTRONIC PS MEDICAL, INC. GWM 2025-02-17 00763000281229 Exacta Pole Clamp with laser level MEDTRONIC PS MEDICAL, INC. GWM 2025-02-16 00763000467401 NA MEDTRONIC PS MEDICAL, INC. GWM 2024-06-01 00763000406073 Becker MEDTRONIC PS MEDICAL, INC. GWM 2024-03-31 20763000467344 NA MEDTRONIC PS MEDICAL, INC. GWM 2024-03-01 20763000467351 NA MEDTRONIC PS MEDICAL, INC. GWM 2024-02-26 20763000467382 NA MEDTRONIC PS MEDICAL, INC. GWM 2024-02-26 20763000467399 NA MEDTRONIC PS MEDICAL, INC. GWM 2024-02-26 00763000406080 NA MEDTRONIC PS MEDICAL, INC. GWM 2024-02-26 00763000431259 Becker MEDTRONIC PS MEDICAL, INC. GWM 2024-02-26 00763000529307 Becker MEDTRONIC PS MEDICAL, INC. GWM 2024-02-26 00763000529369 Becker MEDTRONIC PS MEDICAL, INC. GWM 2024-02-26 00763000572877 Becker MEDTRONIC PS MEDICAL, INC. GWM 2024-02-25 00850013266203 IRRAflow Tube Set Clearpoint Neuro, Inc. GWM 2023-11-02 00763000624774 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2022-03-10 00763000624781 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2022-03-10 00763000624798 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2022-03-10 00763000428723 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2021-03-07 00763000428747 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2021-03-07 00763000428754 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2021-03-07 00763000428761 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2021-03-07 00763000428778 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2021-03-07 00763000431273 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2021-02-13 20763000431307 N/A MEDTRONIC PS MEDICAL, INC. GWM 2021-02-07 00763000395971 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2021-02-07 00763000395988 N/A MEDTRONIC PS MEDICAL, INC. GWM 2021-02-07