Catalog Number

-

Brand Name

Magic Air Surgical

Version/Model Number

MAS45

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K181691

Product Code

EFB

Product Code Name

Handpiece, Air-Powered, Dental

Public Device Record Key

c3cc7a9f-8c14-40cc-839a-1109d4dab43a

Public Version Date

February 18, 2021

Public Version Number

1

DI Record Publish Date

February 10, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-