Catalog Number

CM001

Brand Name

Stylet – Tracheal Tube/ Bougie Catheter

Version/Model Number

CM001

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

e2cde0e8-0a52-4732-9070-9babe9d12123

Public Version Date

December 21, 2020

Public Version Number

3

DI Record Publish Date

June 08, 2020

Package DI Number

10860004198809

Quantity per Package

10

Contains DI Package

00860004198802

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box