Catalog Number

-

Brand Name

AJAX Nail

Version/Model Number

TI-6086L-12-420R

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

K192003

Product Code

JDS

Product Code Name

Nail, Fixation, Bone

Public Device Record Key

d50a9e38-6388-47ce-b573-ebd6a29f2146

Public Version Date

November 06, 2020

Public Version Number

1

DI Record Publish Date

October 29, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-