Catalog Number

PITI-BP 6.0x5.0mm

Brand Name

TatumSurgical/Ball Post for Integrity 6.0-8.0, 6.0 x 5.0mm Cuff Height

Version/Model Number

6.0 x 5mm Integrity ball post

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 21, 2021

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

K811923

Product Code

DZE

Product Code Name

IMPLANT, ENDOSSEOUS, ROOT-FORM

Public Device Record Key

0bc878ae-226c-4ad9-9347-51e4e632e2b3

Public Version Date

January 22, 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

-