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Device Explorer · FDA GUDID · GMDN 61376

Intracerebral infusion/drainage catheter, long-term

A sterile, flexible tube intended to be surgically inserted through the skull for long-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., chemothe

US‑registered devices294in commercial distribution
Companies6labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription82%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Medtronic Ps Medical, Inc.13947%
Sophysa5418%
Integra Lifesciences Production Corporation4014%
Natus Medical Incorporated3010%
Integra Lifesciences Corporation207%
Christoph Miethke Gmbh & Co. Kg114%

Top labelers

CompanyDevicesShare
Medtronic Ps Medical, Inc.13947%
Sophysa5418%
Integra Lifesciences Production Corporation4014%
Natus Medical Incorporated3010%
Integra Lifesciences Corporation207%
Christoph Miethke Gmbh & Co. Kg114%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

XABOAESCULAPPhoenix NeuroSophysaNAInnervisionN/AOpus®Innervision, BioGlide®BioGlide®ARES™Rivulet™Natus®CODMAN® BACTISEAL®CODMAN® HAKIM® BACTISEAL®CODMAN® ACCU-FLO®

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 components301
LKGPORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVENTRICULAR31
JXGShunt, Central Nervous System And Components27
LKGPort & catheter, implanted, subcutaneous, intraventricular17
HCACATHETER, VENTRICULAR15
LKGPort & Catheter, Implanted, Subcutaneous, Intraventricular3

GMDN & GCC registration

  • GMDN code 61376 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 82% · 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) · 84Catheter Length (Centimeter) · 11Width (Millimeter) · 6Catheter Inner Diameter (Millimeter) · 1Catheter Gauge (French) · 1

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

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

294 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Intracerebral infusion/drainage catheter, long-term", from 6 companies. The largest labeler is Medtronic Ps Medical, Inc. with 47% of records.

Which FDA product codes apply?

JXG (Shunt, central nervous system and components), LKG (PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVENTRICULAR), JXG (Shunt, Central Nervous System And Components), LKG (Port & catheter, implanted, subcutaneous, intraventricular)

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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