Catalog Number

AS80251

Brand Name

Repl. Cover , SA-12Hr

Version/Model Number

AS80251

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

K070092,K070092

Product Code

NUV

Product Code Name

Massager, Vacuum, Light Induced Heating

Public Device Record Key

a1004121-d251-4dca-9011-b51a03c25817

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 26, 2016

Package DI Number

17290109950607

Quantity per Package

5

Contains DI Package

07290109950600

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-