Catalog Number

102-0140-100

Brand Name

K-wire 2.0x190mm,trocar/round, 2.0x190mm,f.5.0mm FUSION LOCK SYSTEM

Version/Model Number

102-0140-100

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

-

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

0358af82-d342-4893-ae11-608fcda843eb

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 09, 2016

Package DI Number

EMAH10201401001

Quantity per Package

1

Contains DI Package

EMAH10201401000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-