Catalog Number

IMP-7005

Brand Name

IMPRESS-RITE 380

Version/Model Number

IMP-7005

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

ELW

Product Code Name

Material, Impression

Public Device Record Key

a73e59d4-3726-49fc-bcf5-3cc1cf3ac144

Public Version Date

February 24, 2020

Public Version Number

3

DI Record Publish Date

July 05, 2017

Package DI Number

10818524020643

Quantity per Package

1

Contains DI Package

00818524020646

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

KIT