Catalog Number

VPS-8201

Brand Name

IMPRESS-RITE DISPENSER

Version/Model Number

VPS-8201

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

3a8cb52e-bfe6-49f8-b620-9de8d445dd46

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 05, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-