Acc. Probe, Endo. Straight, 25g

FDA UDI

Class II (US FDA UDI)

by Ellex Medical Pty Ltd

Identity

Trade Name: ACC. PROBE, ENDO. STRAIGHT,25G FDA UDI
Generic Name: Ophthalmic laser system beam guide FDA UDI
Model / Reference: A327000 FDA UDI

Identifiers

Catalog Number: ENDOPROBE STRAIGHT 25G FDA UDI
Primary DI / UDI-DI: 09342395001967 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. Probe, Endo. Straight, 25g by Ellex Medical Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 cf7b25b2-de56-4efa-8217-d5b0110946d8 34 fields · synced May 30, 2026