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Device Explorer · FDA GUDID · GMDN 33596

Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

An electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endos

US‑registered devices3,019in commercial distribution
Companies40labelers on GUDID
Single‑use3%of device records
Sterile2%labelled sterile
Prescription70%Rx‑only share
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Share of device records

Orange Surgical Instruments, Llc54818%
Hermann Medizintechnik Gmbh38513%
Aesculap Ag36712%
Steris Corporation33411%
Richard Wolf Gmbh2849%
Integra Lifesciences Production Corporation2498%
Silex Medical, Llc1525%
Flexbar Machine Corporation1224%

Top labelers

CompanyDevicesShare
Orange Surgical Instruments, Llc54818%
Hermann Medizintechnik Gmbh38513%
Aesculap Ag36712%
Steris Corporation33411%
Richard Wolf Gmbh2849%
Integra Lifesciences Production Corporation2498%
Silex Medical, Llc1525%
Flexbar Machine Corporation1224%
Integra Microfrance963%
Ackermann Instrumente Gmbh752%
Boss Instruments, Ltd., Inc.652%
Gimmi Gmbh642%

Company = labeler of record on GUDID. 40 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NAMixter grasp.fcps. 90°,5/450mmShaft knob,5mmClaw grasp.fcps.insert,5/330mmBabcock grasp.fcps.insert,5/450mmDeBakey grasp.fcps.insert,5/450mmAllis grasp.fcps.insert,5/450mmBowel grasp.fcps.insert,fenestr.,5/450mmBowel grasp.fcps.insert,fenestr.,5/330mmCrocodile grasp.fcps.insert,5/330mmMaxi atraum.grasp.fcps.insert,5/330mmMixter grasp.fcps.insert 90°,5/330mmMicro-fenestrated grasp.fcps.,5/330mmFenestrated grasp.fcps.insert,5/450mmFenestrated grasp.fcps.insert,5/330mmMaryland grasp.fcps.insert ,5/450mm

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

FDA product codes

CodeNameDevices
GCJLaparoscope, general & plastic surgery1,396
GEIElectrosurgical, Cutting & Coagulation & Accessories896
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES772
GCJLaparoscope, General & Plastic Surgery378
GEIElectrosurgical, cutting & coagulation & accessories308
KNFCOAGULATOR-CUTTER, ENDOSCOPIC, UNIPOLAR (AND ACCESSORIES)214

GMDN & GCC registration

  • GMDN code 33596 · non‑implantable
  • Single‑use 3% · sterile 2% · Rx‑only 70% · 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

Outer Diameter (Millimeter) · 459Length (Millimeter) · 119Length (Centimeter) · 79Angle (degree) · 29Length (Inch) · 28Shaft Length (Millimeter) · 3

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

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

3,019 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Endoscopic electrosurgical handpiece/electrode, monopolar, reusable", from 40 companies. The largest labeler is Orange Surgical Instruments, Llc with 18% of records.

Which FDA product codes apply?

GCJ (Laparoscope, general & plastic surgery), GEI (Electrosurgical, Cutting & Coagulation & Accessories), GEI (ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES), 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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