Catalog Number

93805HZ

Brand Name

EQUALINE

Version/Model Number

93805HZ

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

-

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

-

Product Code

LPN

Product Code Name

Accessories, soft lens products

Public Device Record Key

3d6967e0-6149-4f08-bf0d-5ba5fe58e7e6

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 20, 2016

Package DI Number

10041163472546

Quantity per Package

4

Contains DI Package

20041163472543

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case