Catalog Number

CR35238T

Brand Name

Merete® CS Cortical Screw Partly Threaded

Version/Model Number

3.5 38 T10

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

K152187

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Public Device Record Key

15bc8455-2e00-47aa-97ca-5f61563c3b2c

Public Version Date

August 01, 2018

Public Version Number

4

DI Record Publish Date

April 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-