Catalog Number

-

Brand Name

STRADIS

Version/Model Number

41038DKS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 28, 2017

Issuing Agency

In HIBCC

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

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

EIA

Product Code Name

Unit, Operative Dental

Public Device Record Key

9804a0e7-4ef2-404b-944a-b9a1dbd4f8b9

Public Version Date

June 17, 2022

Public Version Number

5

DI Record Publish Date

May 05, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-