Catalog Number

-

Brand Name

Equate

Version/Model Number

EQ11

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 01, 2018

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

-

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

K130753,K130753

Product Code

LRX

Product Code Name

Case, Contact Lens

Public Device Record Key

943f1c46-d076-4e1e-8a63-81a28d94b5b2

Public Version Date

December 05, 2018

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

80078742019198

Quantity per Package

72

Contains DI Package

00078742019192

Package Discontinue Date

December 01, 2018

Package Status

Not in Commercial Distribution

Package Type

-