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Device Explorer · FDA GUDID · GMDN 47890

Disposable surgical irrigation/aspiration system

A device assembly designed to irrigate, wash, and evacuate debris from general soft-tissue and orthopaedic surgical sites (e.g., for soft-tissue wound or bone debridement, site clearing, bone cement residue removal) with a pulsatile jet of sterile fluid (typic

US‑registered devices212in commercial distribution
Companies12labelers on GUDID
Single‑use100%of device records
Sterile97%labelled sterile
Prescription49%Rx‑only share
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Share of device records

Stryker Corporation5225%
Guangzhou Clean Medical Products Manufacturing Corp.3918%
Apex (Guangzhou) Tools & Orthopedics Co.2612%
Apex (Suzhou) Medical Products Company2210%
Beijing Zksk Technology Co.,Ltd209%
Omnia Srl188%
Zimmer Orthopaedic Surgical Products, Inc.126%
Microaire Surgical Instruments Llc115%

Top labelers

CompanyDevicesShare
Stryker Corporation5225%
Guangzhou Clean Medical Products Manufacturing Corp.3918%
Apex (Guangzhou) Tools & Orthopedics Co.2612%
Apex (Suzhou) Medical Products Company2210%
Beijing Zksk Technology Co.,Ltd209%
Omnia Srl188%
Zimmer Orthopaedic Surgical Products, Inc.126%
Microaire Surgical Instruments Llc115%
Taiwan Biomaterial Company Limited52%
Davol Inc.52%
Sirona Dental Systems Gmbh10%
Stiehl Tech, Llc10%

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

Brand names on the register (sample)

InterpulseInterPulseNAAWISmartPulseMICROAIRE®iTool® APEXPULSE™ITOOLMicroPort®itool® ApexPulse™CLEANESTPulsaCleanCLEANpalaJet ®CleanZKSK

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

FDA product codes

CodeNameDevices
FQHLavage, Jet138
FQHLAVAGE, JET76
EFSUnit, Oral Irrigation18
JCXApparatus, Suction, Ward Use, Portable, Ac-Powered5
GCJLaparoscope, General & Plastic Surgery4
GCJLaparoscope, general & plastic surgery2

GMDN & GCC registration

  • GMDN code 47890 · non‑implantable
  • Single‑use 100% · sterile 97% · Rx‑only 49% · 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 (Feet) · 2Outer Diameter (Inch) · 1

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

How many disposable surgical irrigation/aspiration system products are registered in the US?

212 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Disposable surgical irrigation/aspiration system", from 12 companies. The largest labeler is Stryker Corporation with 25% of records.

Which FDA product codes apply?

FQH (Lavage, Jet), FQH (LAVAGE, JET), EFS (Unit, Oral Irrigation), JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered)

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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