Catalog Number

-

Brand Name

Midwest Tradition®

Version/Model Number

790344

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

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

EFB

Product Code Name

Handpiece, Air-Powered, Dental

Public Device Record Key

ce15c6c2-7aec-43b2-9f56-32e32232b9e7

Public Version Date

May 17, 2022

Public Version Number

4

DI Record Publish Date

January 18, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-