Catalog Number

Large Ball Post/5.0mmx3mm

Brand Name

TatumSurgical/Large Ball Post

Version/Model Number

Large Ball Post/5.0mmx3mm

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

K811923

Product Code

DZE

Product Code Name

IMPLANT, ENDOSSEOUS, ROOT-FORM

Public Device Record Key

4a6625ed-8dc6-4d2a-a698-1c7baaca66f4

Public Version Date

June 01, 2020

Public Version Number

2

DI Record Publish Date

July 18, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-