Catalog Number

L27619

Brand Name

Lamaze

Version/Model Number

L27619

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

7c3fc839-46d7-4cf6-a244-cc0f680efc75

Public Version Date

September 13, 2019

Public Version Number

3

DI Record Publish Date

July 01, 2018

Package DI Number

B268L276198

Quantity per Package

4

Contains DI Package

B268L276192

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master