Catalog Number

SO-1002-16

Brand Name

TI Snap-off Screw,self-drilling+ tapping,16mm

Version/Model Number

SO-1002-16

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

881c1ca4-1de2-49d3-89e0-c0264bd5b014

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 23, 2016

Package DI Number

EMAHSO1002161

Quantity per Package

1

Contains DI Package

EMAHSO1002160

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-