Catalog Number

663712M

Brand Name

VARIAX

Version/Model Number

663712M

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K180500,K180500

Product Code

HWC

Product Code Name

Screw, fixation, bone

Public Device Record Key

1c7e9597-0bea-473d-af3e-feee6c47a94d

Public Version Date

August 20, 2018

Public Version Number

1

DI Record Publish Date

July 20, 2018

Package DI Number

37613327378970

Quantity per Package

5

Contains DI Package

07613327378979

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack