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Device Explorer · FDA GUDID · GMDN 35083

Open-surgery stone-retrieval forceps

A hand-held manual surgical instrument designed to grasp and/or manipulate a calculus (i.e., a kidney or gallbladder stone) during an open surgical procedure; additional intended uses may include soft-tissue manipulation (e.g., polyp removal). It is typically

US‑registered devices186in commercial distribution
Companies17labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription72%Rx‑only share
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Share of device records

Sklar Corporation4022%
Steris Corporation2715%
Medicon Eg. Chirurgiemechaniker-Genossenschaft2212%
Ambler Surgical Corp.1810%
Gimmi Gmbh169%
Integra Lifesciences Production Corporation148%
Rz-Medizintechnik Gmbh126%
Hayden Medical, Inc.105%

Top labelers

CompanyDevicesShare
Sklar Corporation4022%
Steris Corporation2715%
Medicon Eg. Chirurgiemechaniker-Genossenschaft2212%
Ambler Surgical Corp.1810%
Gimmi Gmbh169%
Integra Lifesciences Production Corporation148%
Rz-Medizintechnik Gmbh126%
Hayden Medical, Inc.105%
Teleflex Incorporated63%
American Medical Endoscopy, Inc.53%
Br Surgical, Llc42%
Med Saver, Inc.32%

Company = labeler of record on GUDID. 17 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Hermann Medizintechnik GmbHRZ Medizintechnik GmbHGimmiMediconStrauss SurgicalHNM MedicalELMEDELMED INCORPORATEDHayden MedicalBR Surgical, LLCMSI Precision Specialty InstrumentsRANDALL KIDNEY STONE FORCEPSMillenniumAmbler SurgicalSklar®PILLING

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

FDA product codes

CodeNameDevices
GENFORCEPS, GENERAL & PLASTIC SURGERY94
FFNCLAMP, NON-ELECTRICAL25
FGMPROBE AND DIRECTOR, GASTRO-UROLOGY18
GDJClamp, Surgical, General & Plastic Surgery17
KOASURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES)8
GENForceps, General & Plastic Surgery7

GMDN & GCC registration

  • GMDN code 35083 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 72% · 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 (Centimeter) · 6Length (Inch) · 3

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

How many open-surgery stone-retrieval forceps products are registered in the US?

186 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Open-surgery stone-retrieval forceps", from 17 companies. The largest labeler is Sklar Corporation with 22% of records.

Which FDA product codes apply?

GEN (FORCEPS, GENERAL & PLASTIC SURGERY), FFN (CLAMP, NON-ELECTRICAL), FGM (PROBE AND DIRECTOR, GASTRO-UROLOGY), GDJ (Clamp, Surgical, 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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