Catalog Number

-

Brand Name

INTERSURGICAL INTERFORM INTUBATING STYLET, SIZE 10FR, OD 3.3MM

Version/Model Number

8080010

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

254b2236-03df-40db-9f48-703234bb4f80

Public Version Date

February 07, 2022

Public Version Number

2

DI Record Publish Date

October 19, 2021

Package DI Number

05030267110254

Quantity per Package

10

Contains DI Package

05030267108756

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-