Catalog Number

20148001

Brand Name

G-FILES

Version/Model Number

L21 2xG1 2xG2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

EKS

Product Code Name

File, Pulp Canal, Endodontic

Public Device Record Key

ef3db238-5068-498f-8a60-b8cd5e1fb778

Public Version Date

September 09, 2020

Public Version Number

1

DI Record Publish Date

September 01, 2020

Package DI Number

J015201480019

Quantity per Package

10

Contains DI Package

J015201480011

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box