Catalog Number

SPI-040950

Brand Name

Vantage

Version/Model Number

SPI-040950

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

-

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

HWD

Product Code Name

Starter, Bone Screw

Public Device Record Key

4d8ebb7e-3350-43b1-9df6-a0aa307acd5d

Public Version Date

March 31, 2022

Public Version Number

1

DI Record Publish Date

March 23, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-