Catalog Number

40-1014-01

Brand Name

S-Core™

Version/Model Number

40-1014-01

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

K191995,K191995

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

5929556c-6be3-446f-b398-056d2bffb561

Public Version Date

May 16, 2022

Public Version Number

1

DI Record Publish Date

May 06, 2022

Package DI Number

10850017962597

Quantity per Package

10

Contains DI Package

00850017962590

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case