Consulting Wallah › Device Explorer › Procedure kits & trays › Interventional radiology percutaneous-access kit,
Device Explorer · FDA GUDID · GMDN 60437

Interventional radiology percutaneous-access kit, single-use

A collection of various instruments/devices (e.g., introducer sheath, dilator, guides, cannula, needle, angiographic catheter) intended to be used for percutaneous body-access to facilitate a radiological image-guided interventional radiology or surgical proce

US‑registered devices98in commercial distribution
Companies11labelers on GUDID
Single‑use98%of device records
Sterile98%labelled sterile
Prescription39%Rx‑only share
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Share of device records

Shanghai Kindly Medical Instruments Co., Ltd.4849%
H.S. Hospital Service Spa1515%
Mermaid Medical A/S1212%
Progressive Medical, Inc.88%
Elesta Spa44%
Manus Medical, Llc33%
Spectranetics Corporation22%
Medical Action Industries Inc.22%

Top labelers

CompanyDevicesShare
Shanghai Kindly Medical Instruments Co., Ltd.4849%
H.S. Hospital Service Spa1515%
Mermaid Medical A/S1212%
Progressive Medical, Inc.88%
Elesta Spa44%
Manus Medical, Llc33%
Spectranetics Corporation22%
Medical Action Industries Inc.22%
Avid Medical, Inc.22%
Stryker Corporation11%
American Catheter 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)

INT or KDLINTMOLLIQuick-Access™PMICustom Healthcare Systems Inc.CUSTOM HEALTHCARE SYSTEMS INCamerican catheter CORPM-DrainMedical Action IndustriesAVID TruCustomINTRODUCER NEEDLEINTRODUCERElesta - Introducer

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

FDA product codes

CodeNameDevices
DYBIntroducer, Catheter52
GAANeedle, Aspiration And Injection, Disposable19
DREDilator, Vessel, For Percutaneous Catheterization12
GBZCatheter, Cholangiography10
DYBINTRODUCER, CATHETER4
OIPRadiology-diagnostic kit4

GMDN & GCC registration

  • GMDN code 60437 · non‑implantable
  • Single‑use 98% · sterile 98% · Rx‑only 39% · 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 (Millimeter) · 20Catheter Gauge (French) · 14Length (Centimeter) · 12Needle Gauge (Gauge) · 4

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

No closely related category with 50+ devices.

How many interventional radiology percutaneous-access kit, single-use products are registered in the US?

98 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Interventional radiology percutaneous-access kit, single-use", from 11 companies. The largest labeler is Shanghai Kindly Medical Instruments Co., Ltd. with 49% of records.

Which FDA product codes apply?

DYB (Introducer, Catheter), GAA (Needle, Aspiration And Injection, Disposable), DRE (Dilator, Vessel, For Percutaneous Catheterization), GBZ (Catheter, Cholangiography)

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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