Catalog Number

71062017

Brand Name

Jet-X

Version/Model Number

71062017

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

K994143,K994143

Product Code

JDW

Product Code Name

PIN, FIXATION, THREADED

Public Device Record Key

f05b7d2c-1241-437f-91ab-9024f274fb4a

Public Version Date

February 15, 2022

Public Version Number

4

DI Record Publish Date

September 28, 2015

Package DI Number

23596010496014

Quantity per Package

6

Contains DI Package

03596010496010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PKG