Consulting Wallah › Device Explorer › Procedure kits & trays › Brain biopsy procedure kit
Device Explorer · FDA GUDID · GMDN 38563

Brain biopsy procedure kit

A packaged collection of sterile equipment that includes a disposable brain biopsy needle and other supplies used to perform a stereotaxic sampling of brain tissue. This is a single-use device.

US‑registered devices66in commercial distribution
Companies5labelers on GUDID
Single‑use58%of device records
Sterile56%labelled sterile
Prescription74%Rx‑only share
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Share of device records

Medtronic Navigation, Inc.3350%
Izi Medical Products, Llc1523%
Ad-Tech Medical Instrument Corporation1015%
Pajunk Gmbh Medizintechnologie46%
Integra Lifesciences Corporation46%

Top labelers

CompanyDevicesShare
Medtronic Navigation, Inc.3350%
Izi Medical Products, Llc1523%
Ad-Tech Medical Instrument Corporation1015%
Pajunk Gmbh Medizintechnologie46%
Integra Lifesciences Corporation46%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

BRAINPRO STRYKERDisposable Biopsy NeedleDisposable Pre-calibrated Biopsy NeedleBRAINPRODisposable Brain Biopsy Needle KitMDT NAVIGATED BIOPSY, COMPATIABLE 7DSTRYKER NAVIGATED BIOPSY NEEDLE7D Navigated Brain Biopsy NeedleNavigated Biopsy Needle, GPSBLAZER INTRODUCER,BEVEL TIPBlazer Introducer - diamond tipBLAZER:C VASNavigated Brain Biopsy CannulaN/AAutoguideStealth Autoguide™ System

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

FDA product codes

CodeNameDevices
HAWNeurological stereotaxic Instrument59
HAWNeurological Stereotaxic Instrument26
OCJSpinal Channeling Instrument, Vertebroplasty3
FCGBiopsy needle1

GMDN & GCC registration

  • GMDN code 38563 · non‑implantable
  • Single‑use 58% · sterile 56% · Rx‑only 74% · 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 (Millimeter) · 3Outer Diameter (Millimeter) · 2

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

No closely related category with 50+ devices.

How many brain biopsy procedure kit products are registered in the US?

66 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Brain biopsy procedure kit", from 5 companies. The largest labeler is Medtronic Navigation, Inc. with 50% of records.

Which FDA product codes apply?

HAW (Neurological stereotaxic Instrument), HAW (Neurological Stereotaxic Instrument), OCJ (Spinal Channeling Instrument, Vertebroplasty), FCG (Biopsy needle)

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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