Catalog Number

109 0126

Brand Name

EndoPilot contra-angle

Version/Model Number

1:1

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

EKX

Product Code Name

Handpiece, Direct Drive, Ac-Powered

Public Device Record Key

d44828a1-9b99-4202-bad3-57c744757dac

Public Version Date

June 02, 2021

Public Version Number

1

DI Record Publish Date

May 25, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-