Catalog Number

900027

Brand Name

Winch Kyphoplasty ( 15 mm) 11 Gauge Balloon Catheter

Version/Model Number

900027

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 09, 2017

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

-

Product Code

HRX

Product Code Name

Arthroscope

Public Device Record Key

1c756eb3-1406-4b06-ab50-b31b3f068ff1

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 17, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-