Catalog Number

130-6256

Brand Name

NAVITAPER GOLD NITI FILES 6/pk VT 25mm # A1

Version/Model Number

130-6256

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

Yes

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

6d947f2c-cd65-4cc5-ae87-90b26a49c6e5

Public Version Date

March 08, 2021

Public Version Number

1

DI Record Publish Date

February 27, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-