Mr Phaco

FDA UDI

Class I (US FDA UDI)

by Crestpoint Management Ltd.

Identity

Trade Name: MR PHACO FDA UDI
Generic Name: Lacrimal dilator, reusable FDA UDI
Device Name: Alphonso Eye Speculum Newborn, Heavy .039 Stainless Wire, 5mm Closed Square Blade slides inside 8mm Closed Square Blade, Dull Finish on Disk, 27mm Blade Spread, 45mm Overall Length FDA UDI
Model / Reference: PH9031 FDA UDI
Description: Alphonso Eye Speculum Newborn, Heavy .039 Stainless Wire, 5mm Closed Square Blade slides inside 8mm Closed Square Blade, Dull Finish on Disk, 27mm Blade Spread, 45mm Overall Length FDA UDI

Identifiers

Primary DI / UDI-DI: G412PH90310 FDA UDI
FDA Product Code: HNC FDA UDI
GMDN Term: Lacrimal dilator, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.4350 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Lacrimal dilator, reusable

Mr Phaco by Crestpoint Management Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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MILLENNIUM — AVALIGN TECHNOLOGIES, Inc. · Class I
Ambler Surgical — Ambler Surgical, LLC · Class I
Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Crestpoint Management Ltd.

Sources (1)

FDA UDI 2cdc10c1-92e3-428a-a7dd-7114ee555a81 33 fields · synced May 30, 2026