Catalog Number

AS75402

Brand Name

Repl. Cover, SA-4Hr

Version/Model Number

AS75402

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

b2c2e8da-e4c1-490f-836e-85c8078ea21d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 26, 2016

Package DI Number

17290109950584

Quantity per Package

5

Contains DI Package

07290109950587

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-