Catalog Number

02.110.25.035.CG

Brand Name

PLUGGERS

Version/Model Number

02.110.25.035.CG

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

-

Product Code

EKR

Product Code Name

Plugger, Root Canal, Endodontic

Public Device Record Key

44129603-2a70-4d77-972d-a5aa0e3c8afe

Public Version Date

August 22, 2022

Public Version Number

1

DI Record Publish Date

August 14, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-