Catalog Number

-

Brand Name

CORE VALUES

Version/Model Number

400856

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

OHY

Product Code Name

Pill Crusher/Cutter

Public Device Record Key

be599806-1182-47d8-9330-da7440d371f1

Public Version Date

September 08, 2020

Public Version Number

1

DI Record Publish Date

August 31, 2020

Package DI Number

10079573108564

Quantity per Package

6

Contains DI Package

00079573108567

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

inner