Catalog Number

571-292

Brand Name

DIA-X FILE

Version/Model Number

25mm ASSTDX/D3

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

DZA

Product Code Name

Drill, Dental, Intraoral

Public Device Record Key

4dcee0f0-98f0-49f0-8caf-90c9cd35dcf2

Public Version Date

June 04, 2020

Public Version Number

1

DI Record Publish Date

May 27, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-