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Device Explorer · FDA GUDID · GMDN 63231

Ophthalmic surgical irrigation/infusion/aspiration handle, reusable

A hand-held, manual tubular device designed as an interface between an ophthalmic cannula intended for infusion, irrigation and/or aspiration (e.g., a capsular polishing or a cystotome cannula) and associated tubing, to facilitate manipulation of the cannula.

US‑registered devices251in commercial distribution
Companies13labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription71%Rx‑only share
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Share of device records

Ambler Surgical Corp.14658%
Aurora Surgical, Llc3112%
Psi/Eye-Ko, Inc.3012%
Bausch & Lomb Incorporated187%
Medetz Surgical Instruments Llc83%
Krishna Imports Inc73%
Med Saver, Inc.42%
Surgical Direct, Inc.21%

Top labelers

CompanyDevicesShare
Ambler Surgical Corp.14658%
Aurora Surgical, Llc3112%
Psi/Eye-Ko, Inc.3012%
Bausch & Lomb Incorporated187%
Medetz Surgical Instruments Llc83%
Krishna Imports Inc73%
Med Saver, Inc.42%
Surgical Direct, Inc.21%
Duckworth And Kent Limited10%
Medical Technical Products, Inc.10%
Marina Medical Instruments, Inc.10%
Volk Optical Inc.10%

Company = labeler of record on GUDID. 13 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Duckworth & KentIA HandpieceAnodyne SurgicalMarina MedicalVolk Infusion HandleStephens InstrumentsBausch + LombMSI Precision Specialty InstrumentsAmbler SurgicalSurgical DirectNovo SurgicalMedetz Surgical InstrumentsInfusion HandleCannulasBi-Manual Irrigation/AspirationIrrigation and Aspiration

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

FDA product codes

CodeNameDevices
KYGDevice, irrigation, ocular surgery138
HMXCannula, Ophthalmic51
KYGDevice, Irrigation, Ocular Surgery16
HNQHook, Ophthalmic12
HMXCannula, ophthalmic10
HQCUnit, Phacofragmentation9

GMDN & GCC registration

  • GMDN code 63231 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 71% · 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

No structured size data on the register.

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

How many ophthalmic surgical irrigation/infusion/aspiration handle, reusable products are registered in the US?

251 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ophthalmic surgical irrigation/infusion/aspiration handle, reusable", from 13 companies. The largest labeler is Ambler Surgical Corp. with 58% of records.

Which FDA product codes apply?

KYG (Device, irrigation, ocular surgery), HMX (Cannula, Ophthalmic), KYG (Device, Irrigation, Ocular Surgery), HNQ (Hook, Ophthalmic)

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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