Catalog Number

-

Brand Name

Posey Eye Protection

Version/Model Number

NL-EP-01S-NEWBORN

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

d93979de-99c7-45d5-9794-c8a7b4cf30c0

Public Version Date

November 16, 2020

Public Version Number

1

DI Record Publish Date

November 06, 2020

Package DI Number

20852788008150

Quantity per Package

5

Contains DI Package

10852788008153

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box