Catalog Number

39001

Brand Name

Advance Dental Products

Version/Model Number

39001

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

ELW

Product Code Name

MATERIAL, IMPRESSION

Public Device Record Key

4a31a855-46a4-471f-9f32-6a3854efe275

Public Version Date

March 08, 2019

Public Version Number

1

DI Record Publish Date

February 05, 2019

Package DI Number

20850455007116

Quantity per Package

10

Contains DI Package

10850455007119

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case