Consulting Wallah › Device Explorer › Syringes, needles & infusion › Intracerebral infusion/drainage catheter, short-te
Device Explorer · FDA GUDID · GMDN 61399

Intracerebral infusion/drainage catheter, short-term

A flexible tube intended to be surgically inserted through the skull for short-term (= 30 days) subdural access to the brain (e.g., cerebral ventricles, cystic tumours) for cerebrospinal fluid (CSF) drainage and/or infusion of materials (e.g., chemotherapeutic

US‑registered devices70in commercial distribution
Companies7labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription94%Rx‑only share
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Share of device records

Medtronic Ps Medical, Inc.3854%
Integra Lifesciences Production Corporation1826%
Sophysa46%
Natus Medical Incorporated46%
Clearpoint Neuro, Inc.23%
Cook Incorporated23%
Integra Lifesciences Corporation23%

Top labelers

CompanyDevicesShare
Medtronic Ps Medical, Inc.3854%
Integra Lifesciences Production Corporation1826%
Sophysa46%
Natus Medical Incorporated46%
Clearpoint Neuro, Inc.23%
Cook Incorporated23%
Integra Lifesciences Corporation23%

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

Brand names on the register (sample)

Phoenix NeuroSophysaIRRAflow® 2.0 CatheterIRRAflow Catheter 2.0+VentriClearVentriclearBioGlideN/ABecker®EDMBioGlide®NANatus®NATUS EVD 1.9MM ID CAT SETNATUS EXTERNAL DRAINAGE VENTRICULAR CATHETER SETCODMAN® HAKIM® BACTISEAL®

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

FDA product codes

CodeNameDevices
JXGShunt, central nervous system and components72
GWMDEVICE, MONITORING, INTRACRANIAL PRESSURE19
GWMDevice, monitoring, intracranial pressure14
JXGShunt, Central Nervous System And Components11
HCACATHETER, VENTRICULAR7
GWMDevice, Monitoring, Intracranial Pressure2

GMDN & GCC registration

  • GMDN code 61399 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 94% · 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

Length (Centimeter) · 13Catheter Length (Centimeter) · 9Catheter Inner Diameter (Millimeter) · 5Outer Diameter (Millimeter) · 3

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

How many intracerebral infusion/drainage catheter, short-term products are registered in the US?

70 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Intracerebral infusion/drainage catheter, short-term", from 7 companies. The largest labeler is Medtronic Ps Medical, Inc. with 54% of records.

Which FDA product codes apply?

JXG (Shunt, central nervous system and components), GWM (DEVICE, MONITORING, INTRACRANIAL PRESSURE), GWM (Device, monitoring, intracranial pressure), JXG (Shunt, Central Nervous System And Components)

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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