Catalog Number

HCS-ITI 8.0x5.0mm

Brand Name

TatumSurgical/8.0x5.0mm Integrity Implant Healing Cuff

Version/Model Number

8.0x5.0mm Integrity Implant Healing Cuff

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Public Device Record Key

eaea3466-09a1-49ec-9cc2-11ad71068b7a

Public Version Date

June 21, 2021

Public Version Number

3

DI Record Publish Date

July 27, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-