Catalog Number

109 2318

Brand Name

EndoPilot Cap for lip-contact

Version/Model Number

EDP2

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

LQY

Product Code Name

Locator, Root Apex

Public Device Record Key

0f1fd335-d29a-4ab2-ac17-fe6b302ae84a

Public Version Date

June 10, 2021

Public Version Number

1

DI Record Publish Date

June 02, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-