Catalog Number

SH9818WA0

Brand Name

rainbow shine

Version/Model Number

SH9818WA0

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

K160079

Product Code

EIH

Product Code Name

POWDER, PORCELAIN

Public Device Record Key

8e2e869e-ad92-48da-bd5e-ab9febca7823

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

December 20, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-