Catalog Number

-

Brand Name

The First Years

Version/Model Number

Y5288

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

d3f5f7f8-7547-41be-afd9-daf518584357

Public Version Date

September 13, 2019

Public Version Number

3

DI Record Publish Date

February 11, 2017

Package DI Number

B268Y52281

Quantity per Package

1

Contains DI Package

B268Y52880

Package Discontinue Date

-

Package Status

-

Package Type

Retail