Catalog Number

I/MAC8502F /I/MAC8503F /I/MAC8508F

Brand Name

Velopex AquaCut Fluid Abrasion Unit

Version/Model Number

MK5

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

K024105

Product Code

KOJ

Product Code Name

Airbrush

Public Device Record Key

6bd055c7-4244-42de-946e-40e0772122b0

Public Version Date

August 15, 2022

Public Version Number

1

DI Record Publish Date

August 06, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-