Catalog Number

-

Brand Name

Cellfina

Version/Model Number

CK1-EU Rev A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 22, 2016

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

K153677

Product Code

OUP

Product Code Name

Powered Surgical Instrument For Improvement In The Appearance Of Cellulite

Public Device Record Key

26315dd2-aa54-49dc-b278-b5e224ad4b00

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 14, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-