FOOTHOLD - MEDIUM DIABETIC FOOTHOLD - SNGL - EHOB INC

Duns Number:150600252

Device Description: MEDIUM DIABETIC FOOTHOLD - SNGL

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More Product Details

Catalog Number

FH10MDDA010

Brand Name

FOOTHOLD

Version/Model Number

REV00

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

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 Details

Product Code

IQI

Product Code Name

Orthosis, Limb Brace

Device Record Status

Public Device Record Key

80cb0175-c21e-4fa2-b635-d9a52c5b9c33

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

August 21, 2020

Additional Identifiers

Package DI Number

30603354400932

Quantity per Package

4

Contains DI Package

10603354400211

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"EHOB INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 132