Catalog Number

-

Brand Name

BTL Cellutone

Version/Model Number

BTL Cellutone

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

PBX

Product Code Name

Massager, Vacuum, Radio Frequency Induced Heat

Public Device Record Key

d3807f2f-4e84-4257-80ab-e51de86904e8

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 12, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-