Catalog Number

55566-1903-1

Brand Name

ZOMA-Jet

Version/Model Number

10mg Demonstration Kit

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 30, 2021

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

Yes

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

-

FDA Premarket Submission

K991294

Product Code

KZE

Product Code Name

Injector, Fluid, Non-Electrically Powered

Public Device Record Key

382e2321-ca81-45c3-a349-448eb5da4940

Public Version Date

August 19, 2021

Public Version Number

2

DI Record Publish Date

August 01, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-