Catalog Number

-

Brand Name

Endo Dental Spray

Version/Model Number

Endo Dental Spray

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

EAT

Product Code Name

Tester, Pulp

Public Device Record Key

c23e9e3e-9ffc-402e-91ce-26a4a9d31e64

Public Version Date

May 22, 2019

Public Version Number

1

DI Record Publish Date

May 14, 2019

Package DI Number

D872AB20121

Quantity per Package

12

Contains DI Package

D872AB200109

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box