Catalog Number

500081

Brand Name

Emiluma

Version/Model Number

500081

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

EBH

Product Code Name

MATERIAL, IMPRESSION TRAY, RESIN

Public Device Record Key

ff57a7fe-3d13-48c1-8eed-e8aab67e17da

Public Version Date

May 29, 2018

Public Version Number

1

DI Record Publish Date

April 28, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-