Catalog Number

-

Brand Name

Cannulated 1st MPJ Hemi Implant

Version/Model Number

CHI-5CH

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

K102401

Product Code

KWD

Product Code Name

Prosthesis, Toe, Hemi-, Phalangeal

Public Device Record Key

c00ad843-8494-4c05-b8bf-e5f1d0a132c6

Public Version Date

May 27, 2020

Public Version Number

6

DI Record Publish Date

August 04, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-