Catalog Number

HBS-1003-12S

Brand Name

TI HBS self-drilling high compression screw,cannulated,12mm

Version/Model Number

HBS-1003-12S

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

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

-

Product Code

HWC

Product Code Name

Screw, fixation, bone

Public Device Record Key

bad7693e-8c00-4c24-bce4-f2ffdc031b1c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 07, 2016

Package DI Number

EMAHHBS100312S1

Quantity per Package

1

Contains DI Package

EMAHHBS100312S0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-