LAMAZE/JOHN DEERE - LAMAZE JD Chill Teether - TOMY INTERNATIONAL, INC.

Duns Number:065183758

Device Description: LAMAZE JD Chill Teether

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More Product Details

Catalog Number

L27412

Brand Name

LAMAZE/JOHN DEERE

Version/Model Number

L27412

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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 Details

Product Code

KKO

Product Code Name

Ring, Teething, Fluid-Filled

Device Record Status

Public Device Record Key

46d1a14b-7203-4d10-b879-2747a802515f

Public Version Date

October 01, 2019

Public Version Number

1

DI Record Publish Date

September 23, 2019

Additional Identifiers

Package DI Number

B268L274122

Quantity per Package

2

Contains DI Package

B268L274120

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Retail Package

"TOMY INTERNATIONAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 10