Catalog Number

663812S

Brand Name

VARIAX

Version/Model Number

663812S

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

Product Code

HWC

Product Code Name

Screw, fixation, bone

Public Device Record Key

423959b8-f6b6-41e7-80a3-c8ab18cdc563

Public Version Date

August 02, 2018

Public Version Number

1

DI Record Publish Date

July 02, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-