Catalog Number

16515

Brand Name

Pro-ophta@

Version/Model Number

Ocular Sticks

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

-

Product Code

HOZ

Product Code Name

Sponge, Ophthalmic

Public Device Record Key

9cf6a340-d86d-4bfe-a2de-d02cc7ba0763

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 17, 2016

Package DI Number

04021447009735

Quantity per Package

50

Contains DI Package

04021447165158

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Transit Container