Catalog Number

71067306

Brand Name

Jet-X

Version/Model Number

71067306

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

-

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

K120871

Product Code

JDW

Product Code Name

PIN, FIXATION, THREADED

Public Device Record Key

f0d3d5cd-dc3a-47b9-80af-fda673ca562e

Public Version Date

January 31, 2020

Public Version Number

4

DI Record Publish Date

August 25, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-