Catalog Number

10-1105

Brand Name

S-Core™

Version/Model Number

10-1105

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

-

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

fceffbf2-3f03-4a34-a2d6-202c953d2a67

Public Version Date

May 16, 2022

Public Version Number

1

DI Record Publish Date

May 06, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-