Catalog Number

-

Brand Name

Ergoline Passion 40/3 Turbo Power, Soltron S-45 Flirt

Version/Model Number

JK 103 / 40-3

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K151400

Product Code

LEJ

Product Code Name

Booth, Sun Tan

Public Device Record Key

0b54a3ee-141c-4cd1-9cec-2e2a85420fe7

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 08, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-