Catalog Number

MT-400

Brand Name

Montgomery® Thyroplasty Measuring Kit

Version/Model Number

MT-400

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

K972317,K972317

Product Code

MIX

Product Code Name

System, Vocal Cord Medialization

Public Device Record Key

f8d0cf58-bd78-417a-b0f9-243fb673d23c

Public Version Date

August 30, 2022

Public Version Number

5

DI Record Publish Date

September 20, 2015

Package DI Number

EBESMT4001

Quantity per Package

1

Contains DI Package

EBESMT4000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton