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Device Explorer · FDA GUDID · GMDN 61870

Open-surgery electrosurgical handpiece/electrode, monopolar, reusable

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 devices838in commercial distribution
Companies20labelers on GUDID
Single‑use5%of device records
Sterile5%labelled sterile
Prescription79%Rx‑only share
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Share of device records

Elmed Incorporated34942%
Aspen Surgical Products, Inc.14517%
Sopro-Comeg Gmbh11514%
Teleflex Incorporated688%
Medimax Tech Inc.314%
Avalign Technologies, Inc.283%
Sklar Corporation253%
Kirwan Surgical Products Llc162%

Top labelers

CompanyDevicesShare
Elmed Incorporated34942%
Aspen Surgical Products, Inc.14517%
Sopro-Comeg Gmbh11514%
Teleflex Incorporated688%
Medimax Tech Inc.314%
Avalign Technologies, Inc.283%
Sklar Corporation253%
Kirwan Surgical Products Llc162%
Aesculap Ag121%
Accurate Surgical & Scientific Instruments Corporation111%
Chungwoo Co., Ltd.91%
Medisourcenet, Inc81%

Company = labeler of record on GUDID. 20 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Guenter Bissinger Medizintechnik GmbHElectrodeUrethrotomy knifeMonopolar electrodeAESCULAPATRAUMATAMediSourceNet, IncELMEDOlsen MedicalSymmetry OlsenASSIKirwanHayden MedicalBovieMediMax TechBio Protech

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 & Accessories597
GEIElectrosurgical, cutting & coagulation & accessories85
FASELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL72
GCJLaparoscope, general & plastic surgery64
GENForceps, General & Plastic Surgery23
HTDFORCEPS11

GMDN & GCC registration

  • GMDN code 61870 · non‑implantable
  • Single‑use 5% · sterile 5% · Rx‑only 79% · 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 (Inch) · 8Length (Feet) · 2Height (Inch) · 1Outer Diameter (Millimeter) · 1

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

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

838 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, reusable", from 20 companies. The largest labeler is Elmed Incorporated with 42% of records.

Which FDA product codes apply?

GEI (Electrosurgical, Cutting & Coagulation & Accessories), GEI (Electrosurgical, cutting & coagulation & accessories), FAS (ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL), GCJ (Laparoscope, general & plastic surgery)

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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