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Device Explorer · FDA GUDID · GMDN 42433

Intermittent urethral drainage catheter, non-antimicrobial, reusable

A flexible or rigid tube designed to be repeatedly inserted through the urethra, typically by the user (i.e., self-applied), to the urinary bladder to provide short-term, episodic urine drainage (removed after each void), typically for an individual who is phy

US‑registered devices177in commercial distribution
Companies11labelers on GUDID
Single‑use52%of device records
Sterile66%labelled sterile
Prescription99%Rx‑only share
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Share of device records

Amsino International, Inc.3922%
Integra Lifesciences Production Corporation2816%
Teleflex Incorporated2514%
Mckesson Medical-Surgical Inc.2011%
Cardinal Health 200, Llc1810%
Hayden Medical, Inc.169%
Cardinal Health, Inc.158%
Novo Surgical, Inc.74%

Top labelers

CompanyDevicesShare
Amsino International, Inc.3922%
Integra Lifesciences Production Corporation2816%
Teleflex Incorporated2514%
Mckesson Medical-Surgical Inc.2011%
Cardinal Health 200, Llc1810%
Hayden Medical, Inc.169%
Cardinal Health, Inc.158%
Novo Surgical, Inc.74%
Avalign Technologies, Inc.63%
Med Saver, Inc.21%
Ambler Surgical Corp.11%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

RUSCHHayden MedicalMSI Precision Specialty InstrumentsMillenniumAmbler SurgicalDoverAMSure® PVC Intermittent CatheterMcKessonMckessonIntegra® Miltex®Integra® Jarit®Novo Surgical

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

FDA product codes

CodeNameDevices
KODCATHETER, UROLOGICAL62
EZDCatheter, Straight45
FBXSOUND, URETHRAL, METAL OR PLASTIC42
GBMCatheter, Urethral20
GCCDilator, catheter10
GBMCATHETER, URETHRAL10

GMDN & GCC registration

  • GMDN code 42433 · non‑implantable
  • Single‑use 52% · sterile 66% · Rx‑only 99% · 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) · 96Length (Inch) · 22Outer Diameter (Millimeter) · 1

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

How many intermittent urethral drainage catheter, non-antimicrobial, reusable products are registered in the US?

177 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Intermittent urethral drainage catheter, non-antimicrobial, reusable", from 11 companies. The largest labeler is Amsino International, Inc. with 22% of records.

Which FDA product codes apply?

KOD (CATHETER, UROLOGICAL), EZD (Catheter, Straight), FBX (SOUND, URETHRAL, METAL OR PLASTIC), GBM (Catheter, Urethral)

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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