Catalog Number

DYN-IT 00 05-N

Brand Name

JULIET ® INSTRUMENTATION

Version/Model Number

DYN-IT 00 05-N

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 01, 2019

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

-

Product Code

HWA

Product Code Name

Impactor

Public Device Record Key

0ec61a83-dfc8-4ab0-9cdd-5872a035d28e

Public Version Date

April 23, 2019

Public Version Number

2

DI Record Publish Date

February 01, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-