Catalog Number

-

Brand Name

tippy toes by TopCare

Version/Model Number

63250TC

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MEF

Product Code Name

Ring, Teething, Non-Fluid Filled

Public Device Record Key

841ed11e-8a05-4911-9f60-8d339491a528

Public Version Date

August 18, 2020

Public Version Number

1

DI Record Publish Date

August 10, 2020

Package DI Number

20025715033543

Quantity per Package

6

Contains DI Package

00036800400245

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag