Acc. Endo Probe, Angled 25g,

FDA UDI

Class II (US FDA UDI)

by Ellex Medical Pty Ltd

Identity

Trade Name: ACC. ENDO PROBE, ANGLED 25G, FDA UDI
Generic Name: Ophthalmic laser system beam guide FDA UDI
Device Name: ACC. ENDO PROBE, ANGLED 25G, FDA UDI
Model / Reference: A377000 FDA UDI
Description: ACC. ENDO PROBE, ANGLED 25G, FDA UDI

Identifiers

Catalog Number: ENDOPROBE ANGLED 25G FDA UDI
Primary DI / UDI-DI: 09342395001943 FDA UDI
510(k) Number: K050807 FDA UDI
FDA Product Code: HQF FDA UDI
GMDN Term: Ophthalmic laser system beam guide FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 886.4390 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Ophthalmic laser system beam guide

Acc. Endo Probe, Angled 25g, by Ellex Medical Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic laser system beam guide.

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25ga Stiff Illuminated MultiFlex™ Extendable Laser Probe, Iridex Connector — KATALYST SURGICAL, LLC · Class II
Synergetics — SYNERGETICS USA, INC. · Class II
23-27G BriteLight™ Angled 45° EndoProbe® Box of 6 — Iridex Corporation · Class II
OtoProbe™ Long Angled Single — Iridex Corporation · Class II
Synergetics — SYNERGETICS USA, INC. · Class II
OtoProbe™ Short Angled Box of 6 — Iridex Corporation · Class II

Cleared under the same submission

K050807 also covers:

ACC. PROBE, ENDO. STRAIGHT, 20G — ELLEX MEDICAL PTY LTD

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Ellex Medical Pty Ltd

Sources (1)

FDA UDI 1309f1cb-0ccb-446b-9d7d-5b27275955d7 35 fields · synced Jun 8, 2026