Catalog Number

222392

Brand Name

Green Sprouts

Version/Model Number

222392-905-33

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

K093370,K093370,K093370,K093370

Product Code

KKO

Product Code Name

Ring, Teething, Fluid-Filled

Public Device Record Key

9ac2f55b-1fc2-4de4-80f1-38eb72835ac2

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 15, 2016

Package DI Number

30715418091137

Quantity per Package

2

Contains DI Package

20715418091130

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton