Catalog Number

KM71-113

Brand Name

K-Wire w. double end trocarpoint 1.60mm/229mm, 6 pcs./unit

Version/Model Number

KM71-113

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

HTY

Product Code Name

PIN, FIXATION, SMOOTH

Public Device Record Key

6463a199-1ac3-489e-b271-80e89dca7118

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 23, 2016

Package DI Number

EMAHKM711131

Quantity per Package

1

Contains DI Package

EMAHKM711130

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-