Menicon Unique pH Multi-Purpose Solution

FDA UDI

Class II (US FDA UDI)

by Menicon America, Inc.

Identity

Trade Name: Menicon Unique pH Multi-Purpose Solution FDA UDI
Generic Name: Multi-purpose rigid contact lens solution FDA UDI
Model / Reference: 120mL FDA UDI

Identifiers

Primary DI / UDI-DI: 00853253003003 FDA UDI
510(k) Number: K130805 FDA UDI
FDA Product Code: MRC FDA UDI
GMDN Term: Multi-purpose rigid contact lens solution FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 886.5918 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Multi-purpose rigid contact lens solution

Menicon Unique pH Multi-Purpose Solution by Menicon America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Tangible Clean — TANGIBLE SCIENCE Inc · Class II

Cleared under the same submission

K130805 also covers:

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: Menicon America, Inc.

Sources (1)

FDA UDI f7c93c26-c95c-4cd3-a462-88d6a82863d5 33 fields · synced Jun 8, 2026