Catalog Number

GP001A.089.032 STE

Brand Name

KOMET GUIDE PIN/SCREW

Version/Model Number

GP001A.089.032.M4

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,K131264

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

0975721d-8051-4b49-b6dc-242c86a59136

Public Version Date

January 21, 2019

Public Version Number

1

DI Record Publish Date

December 21, 2018

Package DI Number

24053613278939

Quantity per Package

1

Contains DI Package

14053613278932

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

tubular bag