Catalog Number

-

Brand Name

MEDINAUT-V

Version/Model Number

IVP-PU2

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

OAR

Product Code Name

Injector, Vertebroplasty (Does Not Contain Cement)

Public Device Record Key

b770c9f1-f494-4e82-9c0f-c3c0eabeb03f

Public Version Date

August 13, 2018

Public Version Number

1

DI Record Publish Date

July 13, 2018

Package DI Number

08800038026001

Quantity per Package

8

Contains DI Package

08809317171425

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-