Catalog Number

-

Brand Name

TULI'S HEEL CUP REG

Version/Model Number

08140427

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

Yes

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

KNP

Product Code Name

Orthosis, Corrective Shoe

Public Device Record Key

3aa51bd0-083b-46ec-925a-94a8d071a4fe

Public Version Date

August 29, 2022

Public Version Number

1

DI Record Publish Date

August 20, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-