Catalog Number

-

Brand Name

Vertex-Dental BV

Version/Model Number

NOBEOICL01000

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)

-

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

236c4772-b398-4321-b3a7-772d19932945

Public Version Date

April 12, 2018

Public Version Number

1

DI Record Publish Date

March 12, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-