Catalog Number

-

Brand Name

Kit lipofilling face

Version/Model Number

PACK-GOLD

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

Yes

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

K132353,K132353

Product Code

MUU

Product Code Name

System, Suction, Lipoplasty

Public Device Record Key

3682e3f0-c74c-4275-9d52-dfe7d75a67bb

Public Version Date

December 22, 2020

Public Version Number

1

DI Record Publish Date

December 14, 2020

Package DI Number

03701068808153

Quantity per Package

5

Contains DI Package

03701068808146

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box