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Device Explorer · FDA GUDID · GMDN 44681

Electrosurgical handpiece, single-use

A hand-held component of an electrosurgical system intended to provide an electrical connection between the system generator and a detachable electrode at its distal end, enabling the surgeon controlled manipulation of the electrode during surgery; the electro

US‑registered devices215in commercial distribution
Companies29labelers on GUDID
Single‑use97%of device records
Sterile67%labelled sterile
Prescription49%Rx‑only share
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Share of device records

Xodus Medical, Inc.5827%
Zhejiang Shuyou Surgical Instrument Co.,Ltd.4722%
Apyx Medical Corporation167%
Domain Surgical, Inc.136%
Mckesson Medical-Surgical Inc.115%
Soniquence, Llc105%
Bioprotech Inc.105%
Neauvia North America, Inc.73%

Top labelers

CompanyDevicesShare
Xodus Medical, Inc.5827%
Zhejiang Shuyou Surgical Instrument Co.,Ltd.4722%
Apyx Medical Corporation167%
Domain Surgical, Inc.136%
Mckesson Medical-Surgical Inc.115%
Soniquence, Llc105%
Bioprotech Inc.105%
Neauvia North America, Inc.73%
Microline Surgical, Inc.63%
Mynosys Cellular Devices, Inc.63%
Medline Industries, Inc.52%
Med Pen Concepts Llc21%

Company = labeler of record on GUDID. 29 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Mjolnir Pro.Peng’s Multifunctional Operative Dissector(PMOD)NAProfessional Plasma Tip Treatment PackFMwandFMsealerFMXTrabectome HandpieceTRIO HandpiecePlasma IQ Electrode Curved (10 piece)Plasma IQ Electrode Curved (1 piece)Plasma IQ HandpiecePlasma IQ Docking StationPlasma IQ Electrode Straight (10 piece)Plasma IQ Electrode Straight (1 piece)Plasma IQ System

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

FDA product codes

CodeNameDevices
GEIElectrosurgical, Cutting & Coagulation & Accessories170
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES60
GEIElectrosurgical, cutting & coagulation & accessories10
PULApparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powe8
HGIElectrocautery, Gynecologic (And Accessories)6
LFLInstrument, ultrasonic surgical3

GMDN & GCC registration

  • GMDN code 44681 · non‑implantable
  • Single‑use 97% · sterile 67% · Rx‑only 49% · 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 electrosurgical handpiece, single-use products are registered in the US?

215 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Electrosurgical handpiece, single-use", from 29 companies. The largest labeler is Xodus Medical, Inc. with 27% of records.

Which FDA product codes apply?

GEI (Electrosurgical, Cutting & Coagulation & Accessories), GEI (ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES), GEI (Electrosurgical, cutting & coagulation & accessories), PUL (Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powe)

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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