Catalog Number

-

Brand Name

Rexall

Version/Model Number

DG11

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K130753,K130753

Product Code

LRX

Product Code Name

Case, Contact Lens

Public Device Record Key

fa6e36a1-a074-492e-9470-842128a329e4

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 06, 2016

Package DI Number

10897522001502

Quantity per Package

180

Contains DI Package

00897522001505

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-