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Device Explorer · FDA GUDID · GMDN 16763

Intracranial pressure monitor

An 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 signal

US‑registered devices57in commercial distribution
Companies7labelers on GUDID
Single‑use26%of device records
Sterile26%labelled sterile
Prescription95%Rx‑only share
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Share of device records

Braincare Desenvolvimento E Inovacao Tecnologica Sa2442%
Integra Lifesciences Production Corporation2035%
Integra Lifesciences Switzerland Sàrl712%
Branchpoint & Aura Development Llc24%
Natus Medical Incorporated24%
Sophysa12%
Clearpoint Neuro, Inc.12%

Top labelers

CompanyDevicesShare
Braincare Desenvolvimento E Inovacao Tecnologica Sa2442%
Integra Lifesciences Production Corporation2035%
Integra Lifesciences Switzerland Sàrl712%
Branchpoint & Aura Development Llc24%
Natus Medical Incorporated24%
Sophysa12%
Clearpoint Neuro, Inc.12%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SophysaAURAHummingbird® HICP200 Monitor Interconnect Cable NatusCAMINO®Codman® CereLink®DirectLink™CODMAN®CereLink™CODMAN® MICROSENSOR®Codman Microsensor®CODMAN® IPC EXPRESS®CODMAN MICROSENSOR®Braincare

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
GWMDevice, Monitoring, Intracranial Pressure33
GWMDEVICE, MONITORING, INTRACRANIAL PRESSURE29
GWMDevice, monitoring, intracranial pressure26
GYKInstrument, shunt system implantation2

GMDN & GCC registration

  • GMDN code 16763 · non‑implantable
  • Single‑use 26% · sterile 26% · Rx‑only 95% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Width (Millimeter) · 24Length (Millimeter) · 23Height (Millimeter) · 15Catheter Gauge (French) · 2

Use these as the dimensions to specify in a tender line.

No closely related category with 50+ devices.

How many intracranial pressure monitor products are registered in the US?

57 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Intracranial pressure monitor", from 7 companies. The largest labeler is Braincare Desenvolvimento E Inovacao Tecnologica Sa with 42% of records.

Which FDA product codes apply?

GWM (Device, Monitoring, Intracranial Pressure), GWM (DEVICE, MONITORING, INTRACRANIAL PRESSURE), GWM (Device, monitoring, intracranial pressure), GYK (Instrument, shunt system implantation)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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