Catalog Number

E-UR-5

Brand Name

3M™ ESPE™

Version/Model Number

E-UR-5

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

ELZ

Product Code Name

CROWN, PREFORMED

Public Device Record Key

5fbc627c-1d8d-4707-bfe5-d1803070ad32

Public Version Date

March 10, 2021

Public Version Number

2

DI Record Publish Date

September 24, 2018

Package DI Number

50605861034475

Quantity per Package

5

Contains DI Package

30605861034471

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX