Catalog Number

110 0132-US

Brand Name

EndoPilot DownPack expansion set

Version/Model Number

v00

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

K202906

Product Code

EKR

Product Code Name

Plugger, Root Canal, Endodontic

Public Device Record Key

4f794a81-e9bb-4bbb-80e3-73451fe59ffc

Public Version Date

September 20, 2021

Public Version Number

1

DI Record Publish Date

September 10, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-