Consulting Wallah › Device Explorer › Other devices › Automatic cranial perforator, single-use
Device Explorer · FDA GUDID · GMDN 46277

Automatic cranial perforator, single-use

A sterile, metallic rotary endpiece designed to cut a circular section, or sections, of the skull vault (calvarium) to provide access to the interior for diagnostic/therapeutic purposes or for the removal of a bone flap for brain surgery. It typically consists

US‑registered devices85in commercial distribution
Companies8labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription72%Rx‑only share
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Share of device records

Micromar Indústria E Comércio Ltda2428%
Evonos Gmbh & Co. Kg1619%
Phasor Health Llc1518%
Acra-Cut Inc1012%
Emd Endoszkóp Műszer Gyártó És Kereskedelmi Korlátolt Felelősségű Társaság89%
Adeor Medical Ag89%
Integra Lifesciences Production Corporation34%
Stryker Corporation11%

Top labelers

CompanyDevicesShare
Micromar Indústria E Comércio Ltda2428%
Evonos Gmbh & Co. Kg1619%
Phasor Health Llc1518%
Acra-Cut Inc1012%
Emd Endoszkóp Műszer Gyártó És Kereskedelmi Korlátolt Felelősségű Társaság89%
Adeor Medical Ag89%
Integra Lifesciences Production Corporation34%
Stryker Corporation11%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NeuroLineZyphrMeridian PerforatorEvonosACRA-CUTPHASORCODMAN®EasyDrill Cranial Perforator Ø9 x Ø6 x 3mmEasyDrill Cranial Perforator Ø11 x Ø7 x 3mmEasyDrill Cranial Perforator Ø14 x Ø11 x 1,5mmEasyDrill Cranial Perforator Ø14 x Ø11 x 3mm

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

FDA product codes

CodeNameDevices
HBFDrills, Burrs, Trephines & Accessories (Compound, Powered)67
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)15
HBFDRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)7

GMDN & GCC registration

  • GMDN code 46277 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 72% · 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

Outer Diameter (Millimeter) · 4Lumen/Inner Diameter (Millimeter) · 1

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

No closely related category with 50+ devices.

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

85 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Automatic cranial perforator, single-use", from 8 companies. The largest labeler is Micromar Indústria E Comércio Ltda with 28% of records.

Which FDA product codes apply?

HBF (Drills, Burrs, Trephines & Accessories (Compound, Powered)), HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)), HBF (DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED))

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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