Catalog Number

HBS-1002-30S

Brand Name

TI HBS self-drilling high compression screw,cannulated,30mm

Version/Model Number

HBS-1002-30S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

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

4e5874fa-36b8-4ac2-9695-b78f6aa61d1d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 09, 2016

Package DI Number

EMAHHBS100230S1

Quantity per Package

1

Contains DI Package

EMAHHBS100230S0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-