Catalog Number

207

Brand Name

Endo-Eze Irrigator Tip

Version/Model Number

207

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EIC

Product Code Name

SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING

Public Device Record Key

3b74c6f3-f045-4209-af24-cd3de325783e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 21, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-