Catalog Number

-

Brand Name

Lamaze

Version/Model Number

Y5228L

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

9d1a10a5-8ae0-4ae9-8708-ee8dc2cabd4e

Public Version Date

October 21, 2019

Public Version Number

1

DI Record Publish Date

October 11, 2019

Package DI Number

B268Y5288L9

Quantity per Package

4

Contains DI Package

B268Y5288L6

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton