Catalog Number

-

Brand Name

DuaFit®

Version/Model Number

A60 SP173 B

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

K132912

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

065dbb76-8660-46a7-9ecd-09ad1907a9cc

Public Version Date

November 12, 2019

Public Version Number

1

DI Record Publish Date

November 04, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-