Catalog Number

-

Brand Name

CERTAIN® PREVAIL®

Version/Model Number

IIOS5613

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 19, 2019

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

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

DZE

Product Code Name

IMPLANT, ENDOSSEOUS, ROOT-FORM

Public Device Record Key

831ec71d-e7cb-4eda-a2ed-f385e6b69923

Public Version Date

March 10, 2022

Public Version Number

4

DI Record Publish Date

September 04, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-