Catalog Number

BFSDT

Brand Name

Tatum Surgical-Screw Driver

Version/Model Number

BFSDT Bone Fixation Screw Driver Tip

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 09, 2021

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

-

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

DZN

Product Code Name

Instruments, Dental Hand

Public Device Record Key

7de24845-fe14-4d23-9c81-7d42649b93fe

Public Version Date

February 10, 2021

Public Version Number

5

DI Record Publish Date

May 17, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-