Catalog Number

-

Brand Name

Secure IM Nail

Version/Model Number

8960-45

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

K180087,K180087

Product Code

HTY

Product Code Name

Pin, Fixation, Smooth

Public Device Record Key

704b7407-0db4-4efd-81f2-d3849ff90b35

Public Version Date

October 12, 2018

Public Version Number

2

DI Record Publish Date

July 16, 2018

Package DI Number

10857915007061

Quantity per Package

5

Contains DI Package

00857915007064

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case