Catalog Number

824-706

Brand Name

Obtura Spartan

Version/Model Number

824-706

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

K060347,K060347

Product Code

EKR

Product Code Name

PLUGGER, ROOT CANAL, ENDODONTIC

Public Device Record Key

8c7e1cc7-01ac-4df6-9067-cf285356e884

Public Version Date

October 14, 2022

Public Version Number

1

DI Record Publish Date

October 06, 2022

Package DI Number

10843471150051

Quantity per Package

1

Contains DI Package

00843471150054

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACKAGE