Catalog Number

SO-1002-14

Brand Name

TI Snap-off Screw,self-drilling+ tapping,14mm

Version/Model Number

SO-1002-14

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

ef53a69e-45ef-44ff-8646-aa870fd0f65b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 09, 2016

Package DI Number

EMAHSO1002141

Quantity per Package

1

Contains DI Package

EMAHSO1002140

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-