Catalog Number

KM71-243

Brand Name

K-Wire w. lanzet/round end 1.6mm/229mm, 6 pcs./unit

Version/Model Number

KM71-243

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

c5b61402-80ab-4abd-93de-c479defdf5db

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 13, 2016

Package DI Number

EMAHKM712431

Quantity per Package

1

Contains DI Package

EMAHKM712430

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-