Catalog Number

HC ITI 8.0mm Integrity

Brand Name

TatumSurgical/HC ITI 8.0mm Integrity-Delrin HC for Integrity 8.0mm Implant

Version/Model Number

Delrin Healing Cap for Integrity 8.0mm Implant

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 29, 2020

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

1cf3bc6c-3efe-4658-aa87-8d5049315bed

Public Version Date

June 01, 2020

Public Version Number

2

DI Record Publish Date

August 20, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-