Catalog Number

FH10XPEX010

Brand Name

FOOTHOLD

Version/Model Number

REV00

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"

Yes

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

IQI

Product Code Name

Orthosis, Limb Brace

Public Device Record Key

b3d35d0a-9b6a-42c6-a9d5-f5c5989a98ac

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

August 21, 2020

Package DI Number

30603354400796

Quantity per Package

4

Contains DI Package

10603354400525

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box