Catalog Number

-

Brand Name

Verge

Version/Model Number

K2106

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Safe

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)

-

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

20a1b951-4d66-4b6f-b816-bf306a6d97fb

Public Version Date

March 18, 2020

Public Version Number

1

DI Record Publish Date

March 10, 2020

Package DI Number

D915K21062

Quantity per Package

10

Contains DI Package

D915K21061

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-