Catalog Number

SLOT

Brand Name

Bovie

Version/Model Number

SLOT

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

44ca0216-a9dd-4ced-8d38-05f8fac1d77a

Public Version Date

May 25, 2018

Public Version Number

3

DI Record Publish Date

February 10, 2017

Package DI Number

10607151063396

Quantity per Package

1

Contains DI Package

00607151063399

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX