Catalog Number

KM71-174

Brand Name

K-Wire w. trocar/round end 1.37mm/127mm, 6 pcs./unit

Version/Model Number

KM71-174

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

HTY

Product Code Name

PIN, FIXATION, SMOOTH

Public Device Record Key

6f4167cc-5221-46b8-88fe-0abd48948b49

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 25, 2016

Package DI Number

EMAHKM711741

Quantity per Package

1

Contains DI Package

EMAHKM711740

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-