Consulting Wallah › Device Explorer › Other devices › Common bile duct dilator
Device Explorer · FDA GUDID · GMDN 11256

Common bile duct dilator

A hand-held manual surgical instrument designed to dilate the common bile duct, i.e., the union of the cystic and hepatic ducts. It typically consists of a slender hollow or solid body instrument made of metal or plastic in a cylindrical form. It is available

US‑registered devices150in commercial distribution
Companies8labelers on GUDID
Single‑use19%of device records
Sterile0%labelled sterile
Prescription88%Rx‑only share
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Share of device records

Avalign Technologies, Inc.4127%
Novo Surgical, Inc.4027%
Aspen Surgical Products, Inc.2718%
Integra Lifesciences Production Corporation2013%
Rz-Medizintechnik Gmbh107%
Steris Corporation107%
Hayden Medical, Inc.11%
Teleflex Incorporated11%

Top labelers

CompanyDevicesShare
Avalign Technologies, Inc.4127%
Novo Surgical, Inc.4027%
Aspen Surgical Products, Inc.2718%
Integra Lifesciences Production Corporation2013%
Rz-Medizintechnik Gmbh107%
Steris Corporation107%
Hayden Medical, Inc.11%
Teleflex Incorporated11%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

RZ Medizintechnik GmbHSymmetry GarrettSymmetry SurgicalSymmetry RuedemannSymmetry WilderSymmetry BakesSymmetry CastroviejoNovo SurgicalNovo Surgical Inc.Hayden MedicalMillenniumMILLENNIUMAvalignPILLINGV. MuellerIntegra® Jarit®

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

FDA product codes

CodeNameDevices
FGMPROBE AND DIRECTOR, GASTRO-UROLOGY64
HDQDilator, Cervical, Fixed Size23
FFPDilator, Rectal18
FGMProbe And Director, Gastro-Urology18
FFPDILATOR, RECTAL11
FHLScoop11

GMDN & GCC registration

  • GMDN code 11256 · non‑implantable
  • Single‑use 19% · sterile 0% · Rx‑only 88% · 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 (Inch) · 25Width (Millimeter) · 20Circumference (Millimeter) · 2Length (Centimeter) · 1

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

How many common bile duct dilator products are registered in the US?

150 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Common bile duct dilator", from 8 companies. The largest labeler is Avalign Technologies, Inc. with 27% of records.

Which FDA product codes apply?

FGM (PROBE AND DIRECTOR, GASTRO-UROLOGY), HDQ (Dilator, Cervical, Fixed Size), FFP (Dilator, Rectal), FGM (Probe And Director, Gastro-Urology)

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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