Consulting Wallah › Device Explorer › Other devices › Urethral dilator, reusable
Device Explorer · FDA GUDID · GMDN 11265

Urethral dilator, reusable

A slender, solid or hollow, flexible or semi-flexible, surgical instrument designed to dilate the urethra, mainly to treat strictures of the urethra, to facilitate the extraction of stones (renal calculi), and/or to facilitate catheter placement. It is typical

US‑registered devices658in commercial distribution
Companies22labelers on GUDID
Single‑use5%of device records
Sterile7%labelled sterile
Prescription89%Rx‑only share
ShareLinkedIn

Share of device records

Elmed Incorporated12619%
C. R. Bard, Inc.11017%
Rz-Medizintechnik Gmbh558%
Avalign Technologies, Inc.508%
Aesculap Ag447%
Grace Manufacturing, Inc.426%
Aspen Surgical Products, Inc.406%
Novo Surgical, Inc.345%

Top labelers

CompanyDevicesShare
Elmed Incorporated12619%
C. R. Bard, Inc.11017%
Rz-Medizintechnik Gmbh558%
Avalign Technologies, Inc.508%
Aesculap Ag447%
Grace Manufacturing, Inc.426%
Aspen Surgical Products, Inc.406%
Novo Surgical, Inc.345%
Gimmi Gmbh274%
Aesculap, Inc.254%
Princeton Medical Group, Inc.193%
Accurate Surgical & Scientific Instruments Corporation173%

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

Brand names on the register (sample)

NAHermann Medizintechnik GmbHRZ Medizintechnik GmbHFOLEY CatheterVan Buren BougiesGuyon CathetersGimmiAESCULAPArthrex®Symmetry HegarSymmetry HankSymmetry PrattNovo SurgicalNovo Surgical Inc.ELMEDELMED INCORPORATED

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

FDA product codes

CodeNameDevices
HDQDilator, Cervical, Fixed Size168
FAXBOUGIE, UROLOGICAL100
KOASurgical Instruments, G-U, Manual (And Accessories)84
FBXSOUND, URETHRAL, METAL OR PLASTIC64
FBXSound, Urethral, Metal Or Plastic45
FBWFILIFORM AND FILIFORM FOLLOWER43

GMDN & GCC registration

  • GMDN code 11265 · non‑implantable
  • Single‑use 5% · sterile 7% · Rx‑only 89% · 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) · 188Length (Inch) · 34Circumference (Millimeter) · 18Width (Millimeter) · 9Length (Millimeter) · 9Length (Centimeter) · 1

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

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

658 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Urethral dilator, reusable", from 22 companies. The largest labeler is Elmed Incorporated with 19% of records.

Which FDA product codes apply?

HDQ (Dilator, Cervical, Fixed Size), FAX (BOUGIE, UROLOGICAL), KOA (Surgical Instruments, G-U, Manual (And Accessories)), FBX (SOUND, URETHRAL, METAL OR PLASTIC)

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?

Add urethral dilator, reusable to the RFQ basket or use the form below with quantity, specification and delivery location; the Network returns comparable quotes from verified suppliers in 2–5 working days.

Request quotes for Urethral dilator, reusable

Hospitals, pharmacies and distributors anywhere: tell us what you need and the Consulting Wallah Network returns comparable quotes from verified suppliers. No fee for buyers.

Buying urethral dilator, reusable for a hospital group?Free executive assessment: we benchmark your prices and tender structure against the Network.
Book the free assessment

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.

Get quotes →