Catalog Number

-

Brand Name

SCP® Foot & Ankle Kit

Version/Model Number

514.502

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

-

Product Code Name

-

Public Device Record Key

1c2eb66f-603e-40a3-9628-2e68b8216131

Public Version Date

August 23, 2022

Public Version Number

3

DI Record Publish Date

October 23, 2015

Package DI Number

00889024406575

Quantity per Package

4

Contains DI Package

00889024205369

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-