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Device Explorer · FDA GUDID · GMDN 41264

Surgical power tool system control unit, line-powered

A mains electricity (AC-powered) component of a line-powered surgical/dental power tool system intended to step down the electrical power from the mains to supply the handpiece/motor (not included), and may also be intended to regulate some of the functions of

US‑registered devices364in commercial distribution
Companies33labelers on GUDID
Single‑use3%of device records
Sterile3%labelled sterile
Prescription93%Rx‑only share
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Share of device records

Bien-Air Dental Sa11331%
Medtronic Powered Surgical Solutions3810%
Nakanishi Inc.3510%
Bien-Air Surgery Sa329%
Smith & Nephew, Inc.236%
W & H Dentalwerk Bürmoos Gmbh226%
Paragon 28, Inc.144%
Richard Wolf Gmbh103%

Top labelers

CompanyDevicesShare
Bien-Air Dental Sa11331%
Medtronic Powered Surgical Solutions3810%
Nakanishi Inc.3510%
Bien-Air Surgery Sa329%
Smith & Nephew, Inc.236%
W & H Dentalwerk Bürmoos Gmbh226%
Paragon 28, Inc.144%
Richard Wolf Gmbh103%
Peter Brasseler Holdings, Llc103%
Stryker Corporation72%
Cochlear Bone Anchored Solutions Ab72%
De Soutter Medical Limited62%

Company = labeler of record on GUDID. 33 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

RPSCORERemBCOXOSurgical Drive SystemZethonDe Soutter MedicalMulti Pad2Straumann Surgical Motor Pro 2Surgic Pro2 NON-OPTSurgic Pro2 OPTHandpiece StandNLZCalibration BurOSADA EXL-OSI2Tube Holder

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

FDA product codes

CodeNameDevices
EBWController, foot, handpiece and cord96
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handp60
EIAUnit, operative dental54
ERLDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDP45
HBEDRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)39
HABSAW, POWERED, AND ACCESSORIES34

GMDN & GCC registration

  • GMDN code 41264 · non‑implantable
  • Single‑use 3% · sterile 3% · Rx‑only 93% · OTC 1%
  • 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 surgical power tool system control unit, line-powered products are registered in the US?

364 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, line-powered", from 33 companies. The largest labeler is Bien-Air Dental Sa with 31% of records.

Which FDA product codes apply?

EBW (Controller, foot, handpiece and cord), ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handp), EIA (Unit, operative dental), ERL (DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDP)

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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