Catalog Number

MPK-CSST4038T

Brand Name

Malleolar Procedure Kit

Version/Model Number

MPK-CSST4038T-US

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

fc2647de-f992-4670-ba1f-587ca45e8873

Public Version Date

January 12, 2022

Public Version Number

2

DI Record Publish Date

February 17, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-