Catalog Number

OC910.170.040 STE

Brand Name

GUIDE PIN/SCREW

Version/Model Number

OC910.170.040 STE

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

JDW

Product Code Name

Pin, Fixation, Threaded

Public Device Record Key

9aa5c6eb-c7ba-43c4-82d7-972f3db2689d

Public Version Date

September 18, 2019

Public Version Number

1

DI Record Publish Date

September 10, 2019

Package DI Number

24053613279158

Quantity per Package

1

Contains DI Package

14053613279151

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-