Catalog Number

ERBD1

Brand Name

Ena HRI ®

Version/Model Number

ERBD1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K062906

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

db44fc02-5fa9-4a8b-95f9-88f0a9e7dec5

Public Version Date

July 23, 2018

Public Version Number

1

DI Record Publish Date

June 20, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-