Catalog Number

1919

Brand Name

3M™ ESPE™

Version/Model Number

1919

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

Yes

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

KXR

Product Code Name

APPLICATOR, RESIN

Public Device Record Key

a6a01ceb-7e33-4795-8696-89fe286ef31a

Public Version Date

November 08, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2018

Package DI Number

50605861032433

Quantity per Package

10

Contains DI Package

30605861032439

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX