Catalog Number

-

Brand Name

INTERGUIDE TRACHEAL TUBE INTRODUCER (BOUGIE), SIZE 10FR, OD 3.3MM

Version/Model Number

8070010

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

Yes

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

152accd1-a01d-4e76-a443-2bfd9f968107

Public Version Date

February 07, 2022

Public Version Number

2

DI Record Publish Date

October 19, 2021

Package DI Number

05030267110223

Quantity per Package

10

Contains DI Package

05030267108725

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-