Catalog Number

-

Brand Name

POSEY EYE PROTECTORS

Version/Model Number

4644

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FOK

Product Code Name

Pad, Neonatal Eye

Public Device Record Key

7634009a-806b-4727-9949-e8ba3160bc96

Public Version Date

August 12, 2022

Public Version Number

1

DI Record Publish Date

August 04, 2022

Package DI Number

20190676001921

Quantity per Package

24

Contains DI Package

10190676001924

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case