Catalog Number

-

Brand Name

Mckesson

Version/Model Number

 174-OS212100

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K110895,K110895

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

6ef71917-ece1-475d-9bc0-f2c82ff00d9a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 17, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-