Catalog Number

-

Brand Name

MD Resource

Version/Model Number

FL3000M

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

K081593,K081593

Product Code

MUU

Product Code Name

System, Suction, Lipoplasty

Public Device Record Key

ee991b7b-3157-453d-a2d4-cfdb02072643

Public Version Date

September 19, 2019

Public Version Number

1

DI Record Publish Date

September 11, 2019

Package DI Number

10859898006505

Quantity per Package

5

Contains DI Package

00859898006508

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case