Catalog Number

-

Brand Name

GENESYS / FILL NEEDLE 25G KIT [V1, 2ea]

Version/Model Number

9059

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

98560c05-e254-42a3-9757-9651672df2b9

Public Version Date

October 03, 2022

Public Version Number

1

DI Record Publish Date

September 24, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-