Catalog Number

AS77813

Brand Name

Repl. Cover (cream), SA-4Hr, VelaShape II

Version/Model Number

AS77813

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K071872,K071872,K071872

Product Code

NUV

Product Code Name

Massager, Vacuum, Light Induced Heating

Public Device Record Key

78a098ed-d04f-40f7-a565-86cb62cf4dca

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 26, 2016

Package DI Number

37290109950441

Quantity per Package

10

Contains DI Package

07290109950440

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-