Catalog Number

KM71-033

Brand Name

K-Wire w. double end lanzet point 1.57mm/152mm, 6 pcs./unit

Version/Model Number

KM71-033

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

255ebc00-03eb-43da-b81b-dbe53fb0d5a4

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 04, 2016

Package DI Number

EMAHKM710331

Quantity per Package

1

Contains DI Package

EMAHKM710330

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-