Catalog Number

SP002.228.016

Brand Name

KOMET STEINMANN PIN

Version/Model Number

SP002.228.016.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

f92dca74-575d-44a5-9a5f-fc660f86481b

Public Version Date

July 13, 2022

Public Version Number

2

DI Record Publish Date

July 11, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-