Catalog Number

3536133

Brand Name

LEADER

Version/Model Number

3536133

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

c451d767-1f5e-4162-908a-f5cd1963c8a1

Public Version Date

July 02, 2021

Public Version Number

3

DI Record Publish Date

October 21, 2019

Package DI Number

50096295112424

Quantity per Package

12

Contains DI Package

30096295112420

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE