Catalog Number

4646

Brand Name

POSEY

Version/Model Number

4646

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

FOK

Product Code Name

Pad, Neonatal Eye

Public Device Record Key

15169a22-42bd-43dd-aeff-e93e2b778558

Public Version Date

October 14, 2022

Public Version Number

1

DI Record Publish Date

October 06, 2022

Package DI Number

20190676001945

Quantity per Package

24

Contains DI Package

10190676001948

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case