Catalog Number

-

Brand Name

Cellfina System Disposable Tray

Version/Model Number

CK1 rev M

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 18, 2019

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K161885

Product Code

OUP

Product Code Name

Powered Surgical Instrument For Improvement In The Appearance Of Cellulite

Public Device Record Key

6470f4aa-c8e3-44a2-875d-e495daeb6efb

Public Version Date

July 26, 2019

Public Version Number

1

DI Record Publish Date

July 18, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-