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Device Explorer · FDA GUDID · GMDN 61869

Open-surgery electrosurgical handpiece/electrode, monopolar, single-use

A rigid device consisting of combined electrosurgical handpiece and monopolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a vari

US‑registered devices709in commercial distribution
Companies30labelers on GUDID
Single‑use97%of device records
Sterile82%labelled sterile
Prescription93%Rx‑only share
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Share of device records

Aspen Surgical Products, Inc.11616%
I.C. Medical, Inc.10715%
Stryker Corporation7711%
Jiangsu Haize Medical Scientific Development Co.,Ltd.487%
Modern Medical Equipment Mfg. Ltd.487%
Conmed Corporation487%
Medtronic Navigation, Inc.416%
Medtronic, Inc.294%

Top labelers

CompanyDevicesShare
Aspen Surgical Products, Inc.11616%
I.C. Medical, Inc.10715%
Stryker Corporation7711%
Jiangsu Haize Medical Scientific Development Co.,Ltd.487%
Modern Medical Equipment Mfg. Ltd.487%
Conmed Corporation487%
Medtronic Navigation, Inc.416%
Medtronic, Inc.294%
Covidien Lp294%
Smith & Nephew, Inc.274%
Megadyne Medical Products, Inc.233%
New Deantronics Taiwan Ltd.223%

Company = labeler of record on GUDID. 30 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PhotonBladeNeptuneCathayVictanOlympusErbePeng's Multifunctional Operative Dissector(ElectPeng's Multifunctional Operative Dissectors (EleSHINMEDDYONICS RF, CROSSDYONICS RF, HEDGEHOGDYONICS RF, WHIRLWINDNASCULPTORTAC-C IITAC-S

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 & Accessories474
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES195
GEIElectrosurgical, cutting & coagulation & accessories133
HRXARTHROSCOPE19
KNWINSTRUMENT, BIOPSY10
HAMApparatus, Electrosurgical9

GMDN & GCC registration

  • GMDN code 61869 · non‑implantable
  • Single‑use 97% · sterile 82% · Rx‑only 93% · 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

Length (Millimeter) · 33Length (Feet) · 33Length (Meter) · 23Outer Diameter (Millimeter) · 16Length (Inch) · 13Length (Centimeter) · 13

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

How many open-surgery electrosurgical handpiece/electrode, monopolar, single-use products are registered in the US?

709 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Open-surgery electrosurgical handpiece/electrode, monopolar, single-use", from 30 companies. The largest labeler is Aspen Surgical Products, Inc. with 16% of records.

Which FDA product codes apply?

GEI (Electrosurgical, Cutting & Coagulation & Accessories), GEI (ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES), GEI (Electrosurgical, cutting & coagulation & accessories), HRX (ARTHROSCOPE)

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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