Catalog Number

-

Brand Name

Mallinckrodt

Version/Model Number

85865

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)

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

522a2c1a-01cf-44d5-8ee5-022b9a032c9e

Public Version Date

June 30, 2022

Public Version Number

4

DI Record Publish Date

September 20, 2018

Package DI Number

60884522004096

Quantity per Package

20

Contains DI Package

80884522004090

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK