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Device Explorer · FDA GUDID · GMDN 44491

Multi-purpose surgical power tool system, line-powered

An assembly of devices designed to resect bones, tough tissues (e.g., cartilage, ligaments), and soft tissues during a surgical procedure; it is not dedicated to a specific clinical application. It includes a mains electricity (AC-powered) control unit which s

US‑registered devices76in commercial distribution
Companies7labelers on GUDID
Single‑use0%of device records
Sterile1%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Adeor Medical Ag4154%
Karl Storz Gmbh & Co. Kg1216%
Medicon Eg. Chirurgiemechaniker-Genossenschaft811%
Smith & Nephew, Inc.79%
Denjoy Dental Co.,Ltd68%
Mako Surgical Corp.11%
Medtronic Powered Surgical Solutions11%

Top labelers

CompanyDevicesShare
Adeor Medical Ag4154%
Karl Storz Gmbh & Co. Kg1216%
Medicon Eg. Chirurgiemechaniker-Genossenschaft811%
Smith & Nephew, Inc.79%
Denjoy Dental Co.,Ltd68%
Mako Surgical Corp.11%
Medtronic Powered Surgical Solutions11%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Endo MotorVELOCITY ALPHA ™ROTOCUTn.a.UNIDRIVEMediconNADYONICS POWERREAL INTELLIGENCEN/AMidas Rex®

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)41
HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCES21
HBCMOTOR, DRILL, ELECTRIC11
OSHPedicle screw spinal system, adolescent idiopathic scoliosis11
MNHOrthosis, spondylolisthesis spinal fixation11
KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY11

GMDN & GCC registration

  • GMDN code 44491 · non‑implantable
  • Single‑use 0% · sterile 1% · 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

No structured size data on the register.

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

How many multi-purpose surgical power tool system, line-powered products are registered in the US?

76 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Multi-purpose surgical power tool system, line-powered", from 7 companies. The largest labeler is Adeor Medical Ag with 54% of records.

Which FDA product codes apply?

HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)), HWE (INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCES), HBC (MOTOR, DRILL, ELECTRIC), OSH (Pedicle screw spinal system, adolescent idiopathic scoliosis)

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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