Catalog Number

S16TL24

Brand Name

Dynafit System

Version/Model Number

S16TL24

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

-

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

bf8fcb4d-81c6-4d7f-957e-b68c8b334343

Public Version Date

June 29, 2018

Public Version Number

1

DI Record Publish Date

May 29, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-