Catalog Number

-

Brand Name

MANI SPREADERS

Version/Model Number

25mm #25

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EKK

Product Code Name

SPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC

Public Device Record Key

fd33fbe3-dba0-47c8-ab73-b84fc11682e3

Public Version Date

October 17, 2022

Public Version Number

1

DI Record Publish Date

October 08, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-