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Device Explorer · FDA GUDID · GMDN 46705

Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

A rigid or semi-rigid tube (non-illuminating) designed to be inserted into the eye to facilitate infusion, irrigation, and/or aspiration of fluids/gases during ophthalmic surgery (e.g., phacoemulsification, vitreoretinal surgery, sub-Tenon’s anaesthesia, capsu

US‑registered devices2,782in commercial distribution
Companies34labelers on GUDID
Single‑use98%of device records
Sterile82%labelled sterile
Prescription88%Rx‑only share
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Share of device records

Psi/Eye-Ko, Inc.1,23644%
Surgistar, Inc.1957%
Katena Products, Inc.1847%
Beaver-Visitec International, Inc.1606%
Sterimedix Limited1566%
Med Saver, Inc.1566%
Hurricane Medical Inc1465%
Medone Surgical Inc803%

Top labelers

CompanyDevicesShare
Psi/Eye-Ko, Inc.1,23644%
Surgistar, Inc.1957%
Katena Products, Inc.1847%
Beaver-Visitec International, Inc.1606%
Sterimedix Limited1566%
Med Saver, Inc.1566%
Hurricane Medical Inc1465%
Medone Surgical Inc803%
Ambler Surgical Corp.773%
Aktive Srl672%
Bausch & Lomb Gmbh552%
Oasis Medical, Inc.452%

Company = labeler of record on GUDID. 34 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Alcon Grieshaber UltraFlowHydrodissection CannulaeCortex Removal CannulaeFormed Irrigating CystotomesFormed Capsularhexis CystotomesLAMINARTran GoniowashZERO PHACO HP 2.2 30D STEL.12BZERO PHACO HDP 2.2MM 30D 12BZERO PHACO HDP 30DEG 12/BMICS SIL I/A HDP 45° STELL 1/BMICS SIL I/A HDP 45° STELL 12BMICS SILICONE I/A HDPC 45° 1/BMICS SILICONE I/A HDPC 45° 12/BMICS I/A SIL.TIP STRT STEL 12BMICS I/A SIL.TIP STRT STEL 1/B

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

FDA product codes

CodeNameDevices
HMXCannula, Ophthalmic1,740
HMXCannula, ophthalmic411
HNYCystotome282
MEDSterilant, Medical Devices158
MXYCannula,Ophthalmic,Posterior Capsular Polishing,Polyvinyl Ac84
HQCUnit, Phacofragmentation71

GMDN & GCC registration

  • GMDN code 46705 · non‑implantable
  • Single‑use 98% · sterile 82% · Rx‑only 88% · 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

Needle Gauge (Gauge) · 240Length (Millimeter) · 154Outer Diameter (Millimeter) · 9Angle (degree) · 7Length (Centimeter) · 2Lumen/Inner Diameter (Millimeter) · 2

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

How many ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use products are registered in the US?

2,782 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use", from 34 companies. The largest labeler is Psi/Eye-Ko, Inc. with 44% of records.

Which FDA product codes apply?

HMX (Cannula, Ophthalmic), HMX (Cannula, ophthalmic), HNY (Cystotome), MED (Sterilant, Medical Devices)

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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