Catalog Number

-

Brand Name

Eye-Cept Rewetting Drops

Version/Model Number

411

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

Yes

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

K041008

Product Code

LPN

Product Code Name

Accessories, Soft Lens Products

Public Device Record Key

6528b6d9-bc85-49c8-9f0f-c57c7ee895bb

Public Version Date

April 21, 2021

Public Version Number

4

DI Record Publish Date

June 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-