Catalog Number

IS10FRL

Brand Name

CARDINAL HEALTH

Version/Model Number

IS10FRL

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

4f09c3e5-5a0f-4b46-aba4-0f07a5075854

Public Version Date

July 19, 2018

Public Version Number

3

DI Record Publish Date

September 14, 2016

Package DI Number

50885380026865

Quantity per Package

10

Contains DI Package

20885380026864

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE