Consulting Wallah › Device Explorer › Other devices › Lacrimal dilator, reusable
Device Explorer · FDA GUDID · GMDN 35010

Lacrimal dilator, reusable

A hand-held, manual, ophthalmic surgical instrument used for enlarging the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. This is a reusable device.

US‑registered devices439in commercial distribution
Companies35labelers on GUDID
Single‑use2%of device records
Sterile1%labelled sterile
Prescription57%Rx‑only share
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Share of device records

Crestpoint Management Limited9221%
Ambler Surgical Corp.6114%
Bausch & Lomb Incorporated327%
Hnm Stainless, Llc.297%
Avalign Technologies, Inc.235%
Elmed Incorporated194%
Sontec Instruments, Inc.184%
Integra Lifesciences Production Corporation133%

Top labelers

CompanyDevicesShare
Crestpoint Management Limited9221%
Ambler Surgical Corp.6114%
Bausch & Lomb Incorporated327%
Hnm Stainless, Llc.297%
Avalign Technologies, Inc.235%
Elmed Incorporated194%
Sontec Instruments, Inc.184%
Integra Lifesciences Production Corporation133%
Med Saver, Inc.123%
Sklar Corporation113%
Krishna Imports Inc102%
Katena Products, Inc.92%

Company = labeler of record on GUDID. 35 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Duckworth & KentFENTEXHermann Medizintechnik GmbHevonosN.A.AESCULAPLacrimal dilator, reusableBOSS InstrumentsLac. DilatorLacrimal InstrumentsHNM MEDICALNovo Surgical Inc.ELMEDLacrimal DilatorAnodyne SurgicalHayden Medical

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

FDA product codes

CodeNameDevices
HNWDilator, lachrymal144
HNCSpecula, Ophthalmic84
HNLProbe, lachrymal73
HNWDilator, Lachrymal60
HNLProbe, Lachrymal47
LRCINSTRUMENT, ENT MANUAL SURGICAL7

GMDN & GCC registration

  • GMDN code 35010 · non‑implantable
  • Single‑use 2% · sterile 1% · Rx‑only 57% · 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 (Inch) · 6Length (Centimeter) · 3Length (Millimeter) · 1Outer Diameter (Millimeter) · 1

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

How many lacrimal dilator, reusable products are registered in the US?

439 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Lacrimal dilator, reusable", from 35 companies. The largest labeler is Crestpoint Management Limited with 21% of records.

Which FDA product codes apply?

HNW (Dilator, lachrymal), HNC (Specula, Ophthalmic), HNL (Probe, lachrymal), HNW (Dilator, Lachrymal)

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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