Catalog Number

RCSMA57X

Brand Name

HU-FRIEDY

Version/Model Number

RCSMA57X

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

84de1511-1a9f-49d5-84cf-b8d86c6b5a33

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

August 14, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-