Catalog Number

IMP-8140

Brand Name

IMPRESS-RITE HP-MIXING TIPS

Version/Model Number

IMP-8140

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EID

Product Code Name

Syringe, Restorative And Impression Material

Public Device Record Key

5932791f-5671-4c41-9732-000a69245bce

Public Version Date

December 30, 2020

Public Version Number

1

DI Record Publish Date

December 22, 2020

Package DI Number

00818524020707

Quantity per Package

20

Contains DI Package

00818524020691

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BAG