Catalog Number

130-4040

Brand Name

NAVICORE PINK GUTTA PERCHA OBTURATORS 5+1/pk # 40

Version/Model Number

130-4040

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

EKM

Product Code Name

GUTTA-PERCHA

Public Device Record Key

9bab3603-d0af-438b-b445-69452a6e2318

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

-