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Device Explorer · FDA GUDID · GMDN 46486

Gastro-urological director

A slender, rod-like surgical instrument made of metal, typically with groove running along the centre of it distal shaft and/or continuing with an elongated malleable wire loop, that is used to guide other devices or instruments into a selected intracorporeal

US‑registered devices105in commercial distribution
Companies13labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription74%Rx‑only share
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Share of device records

Sontec Instruments, Inc.3634%
Integra Lifesciences Production Corporation1918%
Princeton Medical Group, Inc.1817%
Steris Corporation88%
American Medicals77%
Hayden Medical, Inc.44%
Avalign Technologies, Inc.44%
Aesculap, Inc.33%

Top labelers

CompanyDevicesShare
Sontec Instruments, Inc.3634%
Integra Lifesciences Production Corporation1918%
Princeton Medical Group, Inc.1817%
Steris Corporation88%
American Medicals77%
Hayden Medical, Inc.44%
Avalign Technologies, Inc.44%
Aesculap, Inc.33%
Rigicon, Inc.22%
Boston Scientific Corporation11%
Surgical Direct, Inc.11%
Novo Surgical, Inc.11%

Company = labeler of record on GUDID. 13 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

AESCULAPFurlow Insertion ToolRigicon HL-LEVINE Combo Prosthesis Tool - 10/14 Rigicon Stainless Steel Furlow Insertion ToolHayden MedicalPRINCETONBarr ProbeProbe With EyeGrooved DirectorGrooved Director With Tongue Tie And Probe TipGrooved Director With Tongue TieGROOVED DIRECTORUNIVERSAL PROBELARRY FISTULA PROBEBARR FISTULA PROBEST MARKS FISTULA PROBE

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-UROLOGY45
FGMProbe And Director, Gastro-Urology32
MDMInstrument, Manual, Surgical, General Use21
HXBProbe3
KOASurgical Instruments, G-U, Manual (And Accessories)2
QGAPenile Implant Surgical Accessories1

GMDN & GCC registration

  • GMDN code 46486 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 74% · 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) · 37

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

How many gastro-urological director products are registered in the US?

105 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Gastro-urological director", from 13 companies. The largest labeler is Sontec Instruments, Inc. with 34% of records.

Which FDA product codes apply?

FGM (PROBE AND DIRECTOR, GASTRO-UROLOGY), FGM (Probe And Director, Gastro-Urology), MDM (Instrument, Manual, Surgical, General Use), HXB (Probe)

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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