Catalog Number

35437

Brand Name

Herculite Ultra Flow

Version/Model Number

35437

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

EBF

Product Code Name

MATERIAL, TOOTH SHADE, RESIN

Public Device Record Key

9214d079-59f3-407a-bad3-b0886c8f63af

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-