Catalog Number

JND-011

Brand Name

Jetox

Version/Model Number

Jetox-ND

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FQH

Product Code Name

Lavage, Jet

Public Device Record Key

8d37b03d-95bf-4908-9fe1-fe366995600f

Public Version Date

October 24, 2019

Public Version Number

1

DI Record Publish Date

October 16, 2019

Package DI Number

07290014242234

Quantity per Package

25

Contains DI Package

07290014242241

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-