Catalog Number

423834

Brand Name

ULTRA-DRIVE®

Version/Model Number

423834

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

K031280,K900003

Product Code

JDX

Product Code Name

INSTRUMENT, SURGICAL, SONIC AND ACCESSORY/ATTACHMENT

Public Device Record Key

04b645ba-1595-41a1-9a57-ab72b846646c

Public Version Date

November 22, 2018

Public Version Number

4

DI Record Publish Date

September 25, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-