Catalog Number

-

Brand Name

BTL Unison applicator

Version/Model Number

BTL-284-01

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

71afa24e-f67c-4b3c-9ca2-36be772d1ad8

Public Version Date

November 12, 2018

Public Version Number

1

DI Record Publish Date

October 10, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-