Catalog Number

EDXSP-S

Brand Name

Endodontic Diagnostic Instrument

Version/Model Number

EDXSP-S

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

DZN

Product Code Name

Instruments, Dental Hand

Public Device Record Key

9fa24bb4-c6cf-4825-80a6-d3c59c1b2ba5

Public Version Date

August 17, 2020

Public Version Number

1

DI Record Publish Date

August 08, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-