Catalog Number

SP003.228.024

Brand Name

KOMET STEINMANN PIN

Version/Model Number

SP003.228.024.K4

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

a0027ccb-56a9-4ea4-be3c-8faea27a168d

Public Version Date

December 28, 2020

Public Version Number

1

DI Record Publish Date

December 18, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-