Catalog Number

100-0152-015

Brand Name

Hexalobe screw driver shaft w.Star-Bit 10=2.8mm,(f.2.7/3.5 Screws)

Version/Model Number

100-0152-015

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

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

HXX

Product Code Name

SCREWDRIVER

Public Device Record Key

fba50b43-0f6e-46ec-a66a-6e55d8a54799

Public Version Date

December 17, 2018

Public Version Number

1

DI Record Publish Date

November 14, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-