Catalog Number

-

Brand Name

K2™

Version/Model Number

HEMISET

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

-

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

K023770

Product Code

KWD

Product Code Name

PROSTHESIS, TOE, HEMI-, PHALANGEAL

Public Device Record Key

1553a8dc-bb4f-46be-918e-0f057f5bfa84

Public Version Date

February 21, 2022

Public Version Number

5

DI Record Publish Date

July 25, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-