Catalog Number

-

Brand Name

ELEVARE

Version/Model Number

700 PINK

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

January 01, 2025

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

-

Product Code

OHS

Product Code Name

Light Based Over The Counter Wrinkle Reduction

Public Device Record Key

59a5699b-8e14-450e-85f5-44106e136b60

Public Version Date

February 24, 2020

Public Version Number

3

DI Record Publish Date

October 11, 2016

Package DI Number

26928336800355

Quantity per Package

10

Contains DI Package

16928336800358

Package Discontinue Date

January 01, 2025

Package Status

In Commercial Distribution

Package Type

CARTON