Menicon Unique pH Multi-Purpose Solution - MENICON AMERICA, INC.

Duns Number:034212507

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More Product Details

Catalog Number

-

Brand Name

Menicon Unique pH Multi-Purpose Solution

Version/Model Number

Starter Kit

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K130805

Product Code Details

Product Code

MRC

Product Code Name

Products, Contact Lens Care, Rigid Gas Permeable

Device Record Status

Public Device Record Key

958c80aa-a8da-4bfe-8047-315fe3ca04b7

Public Version Date

January 20, 2020

Public Version Number

4

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MENICON AMERICA, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 7