REFRESH RELIEVA FOR CONTACTS - REFRESH RELIEVA FOR CONTACTS Lubricant Eye Drops - Allergan, Inc.

Duns Number:144796497

Device Description: REFRESH RELIEVA FOR CONTACTS Lubricant Eye Drops

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More Product Details

Catalog Number

-

Brand Name

REFRESH RELIEVA FOR CONTACTS

Version/Model Number

96632

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K190674

Product Code Details

Product Code

LPN

Product Code Name

Accessories, Soft Lens Products

Device Record Status

Public Device Record Key

6203d410-1f05-4d30-a0bb-a24be6d7613e

Public Version Date

November 06, 2020

Public Version Number

2

DI Record Publish Date

August 27, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ALLERGAN, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3
3 A medical device with high risk that requires premarket approval 982
U Unclassified 702