Consulting Wallah › Device Explorer › Catheters & tubes › Suprapubic catheter introducer, reusable
Device Explorer · FDA GUDID · GMDN 32021

Suprapubic catheter introducer, reusable

A rigid surgical instrument(s) intended to gain percutaneous suprapubic access to the urinary bladder, via the lower abdominal wall, for placement of a drainage catheter (not included). It includes a sharp pointed trocar blade and/or a suprapubic access cannul

US‑registered devices131in commercial distribution
Companies6labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription26%Rx‑only share
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Share of device records

Hnm Stainless, Llc.9673%
Integra Lifesciences Production Corporation1915%
Ambler Surgical Corp.108%
Karl Storz Gmbh & Co. Kg32%
Gyrus Acmi, Llc22%
Avalign Technologies, Inc.11%

Top labelers

CompanyDevicesShare
Hnm Stainless, Llc.9673%
Integra Lifesciences Production Corporation1915%
Ambler Surgical Corp.108%
Karl Storz Gmbh & Co. Kg32%
Gyrus Acmi, Llc22%
Avalign Technologies, Inc.11%

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

Brand names on the register (sample)

n.a.HNM MEDICALGyrus ACMIMillenniumAmbler SurgicalIntegra® Jarit®

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

FDA product codes

CodeNameDevices
HTYPin, Fixation, Smooth76
GCJLaparoscope, general & plastic surgery24
FBMCannula And Trocar, Suprapubic, Non-Disposable15
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE10
FBQTrocar, gastro-urology6
HRSPlate, Fixation, Bone4

GMDN & GCC registration

  • GMDN code 32021 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 26% · 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 suprapubic catheter introducer, reusable products are registered in the US?

131 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Suprapubic catheter introducer, reusable", from 6 companies. The largest labeler is Hnm Stainless, Llc. with 73% of records.

Which FDA product codes apply?

HTY (Pin, Fixation, Smooth), GCJ (Laparoscope, general & plastic surgery), FBM (Cannula And Trocar, Suprapubic, Non-Disposable), MDM (INSTRUMENT, MANUAL, SURGICAL, GENERAL USE)

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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