Catalog Number

900028

Brand Name

Winch Kyphoplasty ( 20 mm) 11 Gauge Balloon Catheter

Version/Model Number

900028

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 13, 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

ff8a4611-21d2-42ea-824c-2dd3540f57bb

Public Version Date

January 15, 2020

Public Version Number

3

DI Record Publish Date

May 17, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-