Catalog Number

823-620

Brand Name

Obtura Spartan

Version/Model Number

823-620

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

Yes

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

EKR

Product Code Name

PLUGGER, ROOT CANAL, ENDODONTIC

Public Device Record Key

adfc4424-d7bb-4826-8ff4-f2d92631c7f7

Public Version Date

October 14, 2022

Public Version Number

1

DI Record Publish Date

October 06, 2022

Package DI Number

10843471100315

Quantity per Package

5

Contains DI Package

00843471100318

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACKAGE