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Device Explorer · FDA GUDID · GMDN 57822

Surgical irrigation/aspiration handpiece, reusable

A hand-held device designed to be connected to a separate cannula/tip for both irrigation and aspiration of a surgical site by regulating and directing a stream of pressurized fluid (e.g., sterile water) to the site and facilitating suction of debris from the

US‑registered devices978in commercial distribution
Companies29labelers on GUDID
Single‑use7%of device records
Sterile0%labelled sterile
Prescription79%Rx‑only share
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Share of device records

Pmt Corporation52654%
Karl Storz Gmbh & Co. Kg10311%
Walcott Rx Product Inc9510%
Teleflex Incorporated465%
Transamerican Technologies International323%
Plasdent Corporation313%
Integra Microfrance212%
Rumex International Corp.202%

Top labelers

CompanyDevicesShare
Pmt Corporation52654%
Karl Storz Gmbh & Co. Kg10311%
Walcott Rx Product Inc9510%
Teleflex Incorporated465%
Transamerican Technologies International323%
Plasdent Corporation313%
Integra Microfrance212%
Rumex International Corp.202%
Ace Surgical Supply Co., Inc.162%
Richard Wolf Gmbh111%
Kirwan Surgical Products Llc91%
Dufner - Instrumente Gmbh Fabrik Ärztlicher Instrumente Medizintechnik71%

Company = labeler of record on GUDID. 29 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

DUFNER Instrumente GmbHNAGimmin.a.B.I.O.H.CLEARVISIONAESCULAPDELACROIX-CHEVALIERSingle-Site; daVinci SiPlasdentELMEDROLAND DIRECTIONAL S/I, 7FR. x 10CMROLAND DIRECTIONAL S/I, 12FR. x 8CMROLAND DIRECTIONAL S/I, 10FR. x 8CMROLAND DIRECTIONAL S/I, 7FR. x 8CMROLAND DIRECTIONAL S/I, 5FR. x 10CM

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

FDA product codes

CodeNameDevices
GZXInstrument, Microsurgical707
HMXCannula, ophthalmic98
GEIElectrosurgical, Cutting & Coagulation & Accessories36
EJBHandle, Instrument, Dental32
GCJLaparoscope, general & plastic surgery28
GWGENDOSCOPE, NEUROLOGICAL24

GMDN & GCC registration

  • GMDN code 57822 · non‑implantable
  • Single‑use 7% · sterile 0% · Rx‑only 79% · 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) · 605Length (Inch) · 532Length (Millimeter) · 156Outer Diameter (Millimeter) · 24Length (Centimeter) · 4Lumen/Inner Diameter (Millimeter) · 3

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

How many surgical irrigation/aspiration handpiece, reusable products are registered in the US?

978 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical irrigation/aspiration handpiece, reusable", from 29 companies. The largest labeler is Pmt Corporation with 54% of records.

Which FDA product codes apply?

GZX (Instrument, Microsurgical), HMX (Cannula, ophthalmic), GEI (Electrosurgical, Cutting & Coagulation & Accessories), EJB (Handle, Instrument, Dental)

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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