Catalog Number

-

Brand Name

VIVACE Microneedle Cartridge

Version/Model Number

SH-TIP

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K150409,K150409,K150409,K150409

Product Code

OUH

Product Code Name

Skin Resurfacing Rf Applicator

Public Device Record Key

c55ae95a-8e68-4d21-8df5-b3510c489280

Public Version Date

June 04, 2020

Public Version Number

2

DI Record Publish Date

October 11, 2019

Package DI Number

08800017100357

Quantity per Package

15

Contains DI Package

08800017100234

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Vinyl Package