Catalog Number

IN043-1

Brand Name

N-Force 4.0 Fixation System

Version/Model Number

IN043-1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K132244,K151146

Product Code

HTN

Product Code Name

Washer, Bolt Nut

Public Device Record Key

56e5413b-52a2-4303-b6d1-663197e55cfa

Public Version Date

July 06, 2018

Public Version Number

5

DI Record Publish Date

February 05, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-