Catalog Number

600-TKIT-2C

Brand Name

Professional Medical Surgical Supply, Inc. d / b / a International Direct

Version/Model Number

600-TKIT-2C

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OGV

Product Code Name

Tracheostomy cleaning tray

Public Device Record Key

67ff0a24-e7b5-4070-954a-b70552beb369

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Package DI Number

10814125010984

Quantity per Package

30

Contains DI Package

00814125010987

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case