Catalog Number

SP003.228.024 STE

Brand Name

KOMET STEINMAN PIN

Version/Model Number

SP003.228.024YT

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

K131264,K131264

Product Code

HTY

Product Code Name

Pin, Fixation, Smooth

Public Device Record Key

3709eccf-2c4d-4410-ab8b-f94d1fc0eb66

Public Version Date

December 29, 2021

Public Version Number

1

DI Record Publish Date

December 21, 2021

Package DI Number

24053613285043

Quantity per Package

1

Contains DI Package

14053613285046

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-