Catalog Number

-

Brand Name

n.a.

Version/Model Number

33-46-800-1

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

BSR

Product Code Name

Stylet, Tracheal Tube

Public Device Record Key

cf950a4d-fd29-43f2-abcd-282b4e35154f

Public Version Date

September 10, 2020

Public Version Number

1

DI Record Publish Date

September 02, 2020

Package DI Number

14250105609100

Quantity per Package

5

Contains DI Package

04250105609103

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-