Catalog Number

341004

Brand Name

Montgomery® Tracheal Fenestrator

Version/Model Number

341004

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Unsafe

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

FZT

Product Code Name

Cutter, Surgical

Public Device Record Key

4300159d-e89d-45f0-bfa0-531aa8d25802

Public Version Date

August 30, 2022

Public Version Number

3

DI Record Publish Date

September 20, 2015

Package DI Number

EBES3410041

Quantity per Package

1

Contains DI Package

EBES3410040

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton