Catalog Number

93965HZ

Brand Name

PREMIER

Version/Model Number

93965HZ

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

7e96d958-2eee-443d-8328-832e74407122

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 20, 2016

Package DI Number

10840986010092

Quantity per Package

3

Contains DI Package

00840986010095

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box