Catalog Number

-

Brand Name

MEDINAUT Plus Kyphoplasty System

Version/Model Number

PICD-CA1/ PICD-NDT1

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

K182287

Product Code

HRX

Product Code Name

Arthroscope

Public Device Record Key

ff836d3c-d23c-45e1-a5fd-8455a008eb8a

Public Version Date

June 10, 2019

Public Version Number

1

DI Record Publish Date

May 31, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-