Catalog Number

E0017495-2

Brand Name

Ball Hex Driver

Version/Model Number

E0017495-2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

HWR

Product Code Name

DRIVER, PROSTHESIS

Public Device Record Key

14098429-2110-4daf-8134-1f1892e4d41a

Public Version Date

October 11, 2021

Public Version Number

1

DI Record Publish Date

October 03, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-