Catalog Number

A3-DND-QF-001-WF3

Brand Name

3.5mm Wise-Lock Screws, Self Tapping, Length 38 mm

Version/Model Number

TI-117.038

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K141680

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

b556dc0f-a590-4c57-bc17-d8d3e6d421e1

Public Version Date

June 19, 2020

Public Version Number

3

DI Record Publish Date

November 30, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-