Catalog Number

-

Brand Name

Needle

Version/Model Number

BSN2420

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K060347

Product Code

EKR

Product Code Name

Plugger, Root Canal, Endodontic

Public Device Record Key

195a7273-aa83-4590-ab86-9c17be669a96

Public Version Date

May 29, 2019

Public Version Number

1

DI Record Publish Date

May 21, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-