Catalog Number

-

Brand Name

KYPHON Express II Inflatable Bone Tamp

Version/Model Number

KE202

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

K123771

Product Code

HRX

Product Code Name

Arthroscope

Public Device Record Key

8c6f6b0d-3905-4644-a7b3-a89bc3221d49

Public Version Date

January 07, 2019

Public Version Number

1

DI Record Publish Date

December 06, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-