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Device Explorer · FDA GUDID · GMDN 35361

Stereotactic radiosurgical invasive head frame

A device intended to be affixed to a patient's skull to enable precise localization of an area within the brain targeted for radiosurgical procedures (e.g., radiation treatment of a brain tumour). It is typically an assembly that includes a head ring or a head

US‑registered devices136in commercial distribution
Companies4labelers on GUDID
Single‑use7%of device records
Sterile5%labelled sterile
Prescription85%Rx‑only share
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Share of device records

Integra Lifesciences Corporation8865%
Varian Medical Systems, Inc.2115%
Medtronic Navigation, Inc.1914%
Brainlab Se86%

Top labelers

CompanyDevicesShare
Integra Lifesciences Corporation8865%
Varian Medical Systems, Inc.2115%
Medtronic Navigation, Inc.1914%
Brainlab Se86%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

HeadpinsNot in useVarian POST ASSY, STEREOTACTIC HEAD FRAMEVARIAN HEAD FRAME KITVARIAN HEAD FRAME PACKAGEVARIAN HEAD FRAMECranial Screw - Short/LongHead Frame KitHeadFrame Kit, Couch Adapter, SCCB Kit, & 20 ShHeadFrame Kit w/20 Short + 20 Long Head ScrewsHead Frame Cranial Screws - Long and ShortN/ANAPolestarHead Frame - Post Assembly SetCranial Screw - Long

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 Instrument146
IYEAccelerator, linear, medical39
HAWNeurological Stereotaxic Instrument14
LNHSystem, nuclear magnetic resonance imaging10
HBLHolder, Head, Neurosurgical (Skull Clamp)6
MUJSystem,planning,radiation therapy treatment4

GMDN & GCC registration

  • GMDN code 35361 · non‑implantable
  • Single‑use 7% · sterile 5% · Rx‑only 85% · 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) · 5

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

How many stereotactic radiosurgical invasive head frame products are registered in the US?

136 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Stereotactic radiosurgical invasive head frame", from 4 companies. The largest labeler is Integra Lifesciences Corporation with 65% of records.

Which FDA product codes apply?

HAW (Neurological stereotaxic Instrument), IYE (Accelerator, linear, medical), HAW (Neurological Stereotaxic Instrument), LNH (System, nuclear magnetic resonance imaging)

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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