Catalog Number

-

Brand Name

STRADIS

Version/Model Number

41074BNSII

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 16, 2022

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)

-

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

905ce7d8-05f2-45a9-af2e-7789cbbb7731

Public Version Date

June 17, 2022

Public Version Number

6

DI Record Publish Date

January 02, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-