Catalog Number

-

Brand Name

Bright Starts

Version/Model Number

11721

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

-

Product Code

KKO

Product Code Name

Ring, Teething, Fluid-Filled

Public Device Record Key

4827ffa4-9b83-4a7e-be20-4bc567ce0f83

Public Version Date

November 09, 2018

Public Version Number

1

DI Record Publish Date

October 09, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-