Device Explorer · FDA GUDID · GMDN 35252

Fistula probe

A slender, rod-like, hand-held manual surgical instrument made of flexible metal, with a blunt bulbous tip, designed for use in abnormal body passages or communications (fistulas), usually between two internal organs, or leading from an internal organ to an ex

US‑registered devices115in commercial distribution
Companies6labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription93%Rx‑only share
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Share of device records

Ambler Surgical Corp.5951%
Avalign Technologies, Inc.4438%
Helmut Zepf Medizintechnik Gmbh76%
Storz Am Mark Gmbh33%
Hayden Medical, Inc.11%
Sklar Corporation11%

Top labelers

CompanyDevicesShare
Ambler Surgical Corp.5951%
Avalign Technologies, Inc.4438%
Helmut Zepf Medizintechnik Gmbh76%
Storz Am Mark Gmbh33%
Hayden Medical, Inc.11%
Sklar Corporation11%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Hayden MedicalMillenniumAvalignAmbler Value LineAmbler SurgicalSklar®HELMUT ZEPFSTOMA®

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

FDA product codes

CodeNameDevices
GENFORCEPS, GENERAL & PLASTIC SURGERY34
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE18
KAKPROBE, ENT18
GADRETRACTOR12
HXBPROBE8
HDEHOOK, FIBROID, GYNECOLOGICAL7

GMDN & GCC registration

  • GMDN code 35252 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 93% · 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

No structured size data on the register.

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

How many fistula probe products are registered in the US?

115 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Fistula probe", from 6 companies. The largest labeler is Ambler Surgical Corp. with 51% of records.

Which FDA product codes apply?

GEN (FORCEPS, GENERAL & PLASTIC SURGERY), MDM (INSTRUMENT, MANUAL, SURGICAL, GENERAL USE), KAK (PROBE, ENT), GAD (RETRACTOR)

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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