Catalog Number

-

Brand Name

DynaNail

Version/Model Number

1200-02-5027

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Unsafe

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

HSB

Product Code Name

Rod, Fixation, Intramedullary And Accessories

Public Device Record Key

2cbd2366-6d5f-4a5c-855e-712ed5c57daf

Public Version Date

January 17, 2019

Public Version Number

1

DI Record Publish Date

December 17, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-