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Device Explorer · FDA GUDID · GMDN 35803

Surgical penis clamp, reusable

A hand-held manual surgical instrument designed to grasp the penis for manipulation during surgery (e.g., circumcision). It is typically a clip-like device e.g., with self-retaining levers. The penis is placed into this clamp that closes around or on the organ

US‑registered devices149in commercial distribution
Companies22labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription91%Rx‑only share
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Share of device records

Ambler Surgical Corp.4933%
Medline Industries, Inc.2013%
Sontec Instruments, Inc.128%
Surtex Instruments Ltd.117%
Allied Medical, Llc96%
Aesculap, Inc.64%
Avalign Technologies, Inc.64%
Grace Manufacturing, Inc.64%

Top labelers

CompanyDevicesShare
Ambler Surgical Corp.4933%
Medline Industries, Inc.2013%
Sontec Instruments, Inc.128%
Surtex Instruments Ltd.117%
Allied Medical, Llc96%
Aesculap, Inc.64%
Avalign Technologies, Inc.64%
Grace Manufacturing, Inc.64%
Rz-Medizintechnik Gmbh53%
Aesculap Ag43%
Medicon Eg. Chirurgiemechaniker-Genossenschaft32%
Teleflex Incorporated32%

Company = labeler of record on GUDID. 22 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SurtexRZ Medizintechnik GmbHGimmin.a.AESCULAPMediconSymmetry SurgicalGEN2MSI Precision Specialty InstrumentsStrauss Penis ClampSTOCKMANN PENIS FORCEPSGOMCO CIRCUMCISION CLAMPGOMCO CIRCUMCISION CLAMP CHROMEZIPSER PENIS CLAMPMOGEN CIRCUMCISION CLAMPMILLENNIUM

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

FDA product codes

CodeNameDevices
DWSINSTRUMENTS, SURGICAL, CARDIOVASCULAR41
HFXClamp, Circumcision33
HFXCLAMP, CIRCUMCISION29
GENFORCEPS, GENERAL & PLASTIC SURGERY16
FHACLAMP, PENILE11
FFNCLAMP, NON-ELECTRICAL10

GMDN & GCC registration

  • GMDN code 35803 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 91% · 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

Lumen/Inner Diameter (Millimeter) · 15Length (Inch) · 7Outer Diameter (Millimeter) · 5

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

How many surgical penis clamp, reusable products are registered in the US?

149 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical penis clamp, reusable", from 22 companies. The largest labeler is Ambler Surgical Corp. with 33% of records.

Which FDA product codes apply?

DWS (INSTRUMENTS, SURGICAL, CARDIOVASCULAR), HFX (Clamp, Circumcision), HFX (CLAMP, CIRCUMCISION), GEN (FORCEPS, 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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