Catalog Number

-

Brand Name

Apex

Version/Model Number

70071

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)

Yes

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

OHY

Product Code Name

Pill Crusher/Cutter

Public Device Record Key

1e4d2f4f-8a50-4273-a0fc-e874531e5bf5

Public Version Date

August 25, 2020

Public Version Number

3

DI Record Publish Date

August 13, 2019

Package DI Number

30076855700717

Quantity per Package

48

Contains DI Package

00076855700716

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-