Catalog Number

-

Brand Name

Apex

Version/Model Number

70068

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)

-

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

9f0880eb-93d5-40ff-b9a0-037f7519a0c3

Public Version Date

September 01, 2020

Public Version Number

1

DI Record Publish Date

August 24, 2020

Package DI Number

30076855700687

Quantity per Package

144

Contains DI Package

00076855700686

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-