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Device Explorer · FDA GUDID · GMDN 13643

Urethral sound, reusable

A hand-held manual surgical instrument designed to explore and measure the urethra. It is a slender hollow or solid cylindrical instrument made of metal or plastic typically with graduations of length displayed along its working end. It is typically available

US‑registered devices1,051in commercial distribution
Companies19labelers on GUDID
Single‑use2%of device records
Sterile0%labelled sterile
Prescription73%Rx‑only share
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Share of device records

Sklar Corporation20219%
Integra Lifesciences Production Corporation16516%
Grace Manufacturing, Inc.959%
Hayden Medical, Inc.898%
Avalign Technologies, Inc.798%
Steris Corporation737%
Novo Surgical, Inc.697%
Elmed Incorporated636%

Top labelers

CompanyDevicesShare
Sklar Corporation20219%
Integra Lifesciences Production Corporation16516%
Grace Manufacturing, Inc.959%
Hayden Medical, Inc.898%
Avalign Technologies, Inc.798%
Steris Corporation737%
Novo Surgical, Inc.697%
Elmed Incorporated636%
Br Surgical, Llc565%
Aesculap, Inc.444%
Aspen Surgical Products, Inc.323%
Teleflex Incorporated313%

Company = labeler of record on GUDID. 19 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

AESCULAPMediconSymmetry Van BurenSymmetry McCreaSymmetry MccreaNovo SurgicalNovo Surgical Inc.ELMEDBlack & Black SurgicalN/AHayden MedicalMarina MedicalBR Surgical, LLCELMED INCORPORATEDMSI Precision Specialty InstrumentsVAN BUREN URETHRAL SOUND

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

FDA product codes

CodeNameDevices
FBXSOUND, URETHRAL, METAL OR PLASTIC686
FBXSound, Urethral, Metal Or Plastic210
KOASurgical Instruments, G-U, Manual (And Accessories)57
HHMSOUND, UTERINE56
HDQDilator, Cervical, Fixed Size18
FBSSOUND, METAL, INTERCONNECTED15

GMDN & GCC registration

  • GMDN code 13643 · non‑implantable
  • Single‑use 2% · sterile 0% · Rx‑only 73% · 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

Catheter Gauge (French) · 193Length (Inch) · 99Length (Centimeter) · 29Length (Millimeter) · 15Width (Millimeter) · 1

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

How many urethral sound, reusable products are registered in the US?

1,051 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Urethral sound, reusable", from 19 companies. The largest labeler is Sklar Corporation with 19% of records.

Which FDA product codes apply?

FBX (SOUND, URETHRAL, METAL OR PLASTIC), FBX (Sound, Urethral, Metal Or Plastic), KOA (Surgical Instruments, G-U, Manual (And Accessories)), HHM (SOUND, UTERINE)

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.

How do I get quotes?

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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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