Catalog Number

-

Brand Name

MANI MEDIUM H-FILES

Version/Model Number

21MM #27

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

EKS

Product Code Name

FILE, PULP CANAL, ENDODONTIC

Public Device Record Key

7c3e3227-b165-4e75-a217-f1b7a78ca8c8

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

-