Catalog Number

MT-225

Brand Name

Montgomery® Thyroplasty Instrument Tray

Version/Model Number

MT-225

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

-

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

9c39d642-b63f-4a86-9de4-ed1bb5bf3348

Public Version Date

September 16, 2022

Public Version Number

2

DI Record Publish Date

August 31, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-