Catalog Number

MT-200P

Brand Name

Montgomery® Thyroplasty Instrument Set

Version/Model Number

MT-200P

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

-

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

Product Code

MIX

Product Code Name

System, Vocal Cord Medialization

Public Device Record Key

5a27f482-eb0a-4492-ba23-d328c663e0d2

Public Version Date

August 30, 2022

Public Version Number

4

DI Record Publish Date

September 20, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-