Catalog Number

02-029-99-1004

Brand Name

GUIDE PIN/SCREW

Version/Model Number

02-029-99-1004

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

d7b4cc62-f5c4-49de-83df-a02ff8869c3e

Public Version Date

January 24, 2022

Public Version Number

1

DI Record Publish Date

January 14, 2022

Package DI Number

24053613285142

Quantity per Package

1

Contains DI Package

14053613285145

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-