Consulting Wallah › Device Explorer › IVD & laboratory › Surgical power tool system control unit, pneumatic
Device Explorer · FDA GUDID · GMDN 41267

Surgical power tool system control unit, pneumatic

A pneumatically-powered (gas-powered) component of a surgical power tool system intended to regulate the gas pressure supplied to the pneumatic handpiece/motor (not included) and may also be intended to regulate some of the functions of the connected power too

US‑registered devices165in commercial distribution
Companies4labelers on GUDID
Single‑use0%of device records
Sterile3%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Medtronic Powered Surgical Solutions9960%
Medtronic Xomed, Inc.6338%
Medtronic Ps Medical, Inc.21%
Clarus Medical, Llc11%

Top labelers

CompanyDevicesShare
Medtronic Powered Surgical Solutions9960%
Medtronic Xomed, Inc.6338%
Medtronic Ps Medical, Inc.21%
Clarus Medical, Llc11%

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

Brand names on the register (sample)

VISAO™Visao™XPS® Straightshot®N/AMIDAS REX MR8MIDAS REX STEALTH-MIDAS MR8MIDAS REX MR7MIDAS REX LEGENDMidas RexENT MR8Midas Rex LegendMIDAS REXIndigoMidas Rex MR8XPS Nexus™XPS® Micro

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

FDA product codes

CodeNameDevices
HBBMOTOR, DRILL, PNEUMATIC56
ERLDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDP50
KFKSAW, PNEUMATICALLY POWERED34
HBEDRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)30
HBCMOTOR, DRILL, ELECTRIC13
HBANEUROSURGICAL PADDIE7

GMDN & GCC registration

  • GMDN code 41267 · non‑implantable
  • Single‑use 0% · sterile 3% · Rx‑only 100% · 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

Width (Millimeter) · 6Length (Millimeter) · 6

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

How many surgical power tool system control unit, pneumatic products are registered in the US?

165 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical power tool system control unit, pneumatic", from 4 companies. The largest labeler is Medtronic Powered Surgical Solutions with 60% of records.

Which FDA product codes apply?

HBB (MOTOR, DRILL, PNEUMATIC), ERL (DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDP), KFK (SAW, PNEUMATICALLY POWERED), HBE (DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, 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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