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Device Explorer · FDA GUDID · GMDN 47625

Surgical irrigation/aspiration tubing set

A collection of flexible, noninvasive, double-lumen tubing and associated items intended to provide twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution (e.g., saline) from its source (e.g., gravity feed bag) to a surgical ca

US‑registered devices384in commercial distribution
Companies60labelers on GUDID
Single‑use93%of device records
Sterile88%labelled sterile
Prescription81%Rx‑only share
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Share of device records

Promepla8522%
Medline Industries, Inc.308%
Aktive Srl246%
Stryker Corporation215%
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.215%
Synthes Gmbh174%
Lagis Enterprise Co., Ltd.154%
Purple Surgical International Limited92%

Top labelers

CompanyDevicesShare
Promepla8522%
Medline Industries, Inc.308%
Aktive Srl246%
Stryker Corporation215%
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.215%
Synthes Gmbh174%
Lagis Enterprise Co., Ltd.154%
Purple Surgical International Limited92%
Mentor Texas L.P.92%
Hk Surgical Inc.92%
Hemodia82%
Genicon, Inc.82%

Company = labeler of record on GUDID. 60 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

CrossFlowTPSFloControl, Fluid SafeFloSteadyNAAHTOStrykeFlowGOBENDual Action Pump HandDual Action Pump FootRECOTHROM SPRAY KITUlimate Suction/Irrigation probeUltimate Suction / Irrigation probeUltimate Suction/Irrigation probeUltimate Laparoscopic Suction Irrigation probe, Ultimate Laparoscopic Suction/Irrigation Set, Si

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

FDA product codes

CodeNameDevices
FHFSystem, Evacuator, Fluid48
GBXCatheter, Irrigation41
GCJLaparoscope, General & Plastic Surgery33
KGZAccessories, Catheter27
GAZTubing, Noninvasive26
HQCUnit, Phacofragmentation25

GMDN & GCC registration

  • GMDN code 47625 · non‑implantable
  • Single‑use 93% · sterile 88% · Rx‑only 81% · OTC 6%
  • 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) · 9Length (Meter) · 4Length (Centimeter) · 3Circumference (Millimeter) · 2Outer Diameter (Millimeter) · 2Lumen/Inner Diameter (Millimeter) · 1

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

How many surgical irrigation/aspiration tubing set products are registered in the US?

384 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical irrigation/aspiration tubing set", from 60 companies. The largest labeler is Promepla with 22% of records.

Which FDA product codes apply?

FHF (System, Evacuator, Fluid), GBX (Catheter, Irrigation), GCJ (Laparoscope, General & Plastic Surgery), KGZ (Accessories, Catheter)

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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