Catalog Number

-

Brand Name

Count-Tainer 40

Version/Model Number

5100F

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

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K790405,K790405

Product Code

MMK

Product Code Name

Container, Sharps

Public Device Record Key

a787a354-a958-46d2-935e-3ba3d2346368

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 19, 2016

Package DI Number

10612376000125

Quantity per Package

10

Contains DI Package

00612376000128

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-