Catalog Number

-

Brand Name

NA

Version/Model Number

CATHTRAY

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"

Yes

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

-

Product Code

KDD

Product Code Name

Kit, Surgical Instrument, Disposable

Public Device Record Key

702e8b30-1cf1-4988-b83c-a9dfcf0ccbeb

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 20, 2016

Package DI Number

10858778006505

Quantity per Package

5

Contains DI Package

00858778006508

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton