Consulting Wallah › Device Explorer › Other devices › Cranial trephine, single-use
Device Explorer · FDA GUDID · GMDN 46272

Cranial trephine, single-use

A neurosurgical blade used to cut/remove circular sections of the skull vault (calvarium) to provide access to the interior, e.g., for the insertion of a catheter or a neuroscope for diagnosis, or treatments such as, to alleviate intracranial pressure (ICP), o

US‑registered devices62in commercial distribution
Companies2labelers on GUDID
Single‑use98%of device records
Sterile98%labelled sterile
Prescription56%Rx‑only share
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Share of device records

Phasor Health Llc4471%
Acra-Cut Inc1829%

Top labelers

CompanyDevicesShare
Phasor Health Llc4471%
Acra-Cut Inc1829%

Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Wire Pass DrillCranial Blade Disposable low speedCranial Blade Disposable Low SpeedDisposable Cranial PerforatorPHASOR

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

FDA product codes

CodeNameDevices
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)49
HBFDrills, Burrs, Trephines & Accessories (Compound, Powered)12
OJGNeurological Tray11
HBGDrills, Burrs, Trephines & Accessories (Manual)3
HBEDRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)1

GMDN & GCC registration

  • GMDN code 46272 · non‑implantable
  • Single‑use 98% · sterile 98% · Rx‑only 56% · 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

No structured size data on the register.

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

How many cranial trephine, single-use products are registered in the US?

62 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cranial trephine, single-use", from 2 companies. The largest labeler is Phasor Health Llc with 71% of records.

Which FDA product codes apply?

HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)), HBF (Drills, Burrs, Trephines & Accessories (Compound, Powered)), OJG (Neurological Tray), HBG (Drills, Burrs, Trephines & Accessories (Manual))

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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