Catalog Number

-

Brand Name

MicroAire®

Version/Model Number

PAL-R30MLS

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"

-

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

K171286

Product Code

MUU

Product Code Name

System, Suction, Lipoplasty

Public Device Record Key

d9929400-a367-4b3e-878d-fbaf890dbd12

Public Version Date

February 02, 2021

Public Version Number

1

DI Record Publish Date

January 25, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-