Home GUDID G460SP1010 AURA
Primary DI G460SP1010
Brand AURA
Company Branchpoint & Aura Development LLC
Model SP101
Catalog number SP101
Device description AURA™ Sensor Tray
Published 2024-01-09
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety MR Unsafe
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 G460SP1010 Primary HIBCC 0
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.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Atmospheric Pressure 50 KiloPascal 105 KiloPascal Storage Environment Humidity 20 Percent (%) Relative Humidity 85 Percent (%) Relative Humidity Storage Environment Temperature 0 Degrees Celsius 50 Degrees Celsius
Regulatory Flags# DUNS number 063237649 Device count 1 Kit true Lot or batch true 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 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 00763000406004 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2021-02-07 00763000406011 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2021-02-07
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