Catalog Number

-

Brand Name

Endodontic Specialists of Northern Colorado Endo Ice

Version/Model Number

MF-316447

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)

-

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

95988b50-e6fb-4808-9c16-da21ddc5f25e

Public Version Date

March 19, 2019

Public Version Number

1

DI Record Publish Date

March 11, 2019

Package DI Number

10860177000640

Quantity per Package

12

Contains DI Package

00860177000643

Package Discontinue Date

September 24, 2018

Package Status

Not in Commercial Distribution

Package Type

case