Consulting Wallah › Device Explorer › Syringes, needles & infusion › Ophthalmic needle, single-use
Device Explorer · FDA GUDID · GMDN 47610

Ophthalmic needle, single-use

A slender, straight hollow instrument, usually with a sharp bevelled end, designed to be used with a syringe for the transient delivery of fluid materials (e.g., anaesthetic agents, therapeutic drugs) to various structures in and around the eye, including the

US‑registered devices205in commercial distribution
Companies10labelers on GUDID
Single‑use100%of device records
Sterile79%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Psi/Eye-Ko, Inc.12661%
Katena Products, Inc.2512%
Med Saver, Inc.147%
Sterimedix Limited136%
Tsk Laboratory International Japan K.K.94%
Oasis Medical, Inc.84%
Sight Sciences, Inc.42%
Genentech, Inc.31%

Top labelers

CompanyDevicesShare
Psi/Eye-Ko, Inc.12661%
Katena Products, Inc.2512%
Med Saver, Inc.147%
Sterimedix Limited136%
Tsk Laboratory International Japan K.K.94%
Oasis Medical, Inc.84%
Sight Sciences, Inc.42%
Genentech, Inc.31%
Altaviz, Llc21%
Beaver-Visitec International, Inc.10%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Anaesthetic NeedlesSTERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDSSTERiJECT OPHTHALMIC NEEDLE™Apellis Injection KitOMNI Edge Surgical SystemOMNI Ultra Surgical SystemOMNI Surgical SystemOphthalmic cannulaDisposable InstrumentsBLINKOph. CannulaOphthalmic CannulaNeedle aspiration and injection"DISP PERIBULBAR NEEDLE 25GA 7/8"" 10/BOX"Anodyne SurgicalWalcott Rx Products

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

FDA product codes

CodeNameDevices
GAANeedle, Aspiration And Injection, Disposable136
GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE33
MEDSterilant, Medical Devices14
QYMOphthalmic Needle9
MRHPump, Infusion, Ophthalmic7
HMZTrabeculotome6

GMDN & GCC registration

  • GMDN code 47610 · non‑implantable
  • Single‑use 100% · sterile 79% · Rx‑only 100% · 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) · 11Length (Millimeter) · 7Outer Diameter (Millimeter) · 5Length (Inch) · 3

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

How many ophthalmic needle, single-use products are registered in the US?

205 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ophthalmic needle, single-use", from 10 companies. The largest labeler is Psi/Eye-Ko, Inc. with 61% of records.

Which FDA product codes apply?

GAA (Needle, Aspiration And Injection, Disposable), GAA (NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE), MED (Sterilant, Medical Devices), QYM (Ophthalmic Needle)

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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