Catalog Number

-

Brand Name

OIC Cannulated Screw System

Version/Model Number

01-4005

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

-

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

K113123

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

93dd5b8d-96a5-44a6-8422-c65d4621a230

Public Version Date

April 06, 2020

Public Version Number

3

DI Record Publish Date

July 31, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-