Catalog Number

3536125

Brand Name

LEADER

Version/Model Number

3536125

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

b06868a0-4df2-4df2-be29-c889c2ec2204

Public Version Date

July 02, 2021

Public Version Number

3

DI Record Publish Date

October 21, 2019

Package DI Number

50096295112417

Quantity per Package

12

Contains DI Package

30096295112413

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE