K-WIRE - The NEWDEAL K-WIRE is available in four different - NEWDEAL

Duns Number:536935331

Device Description: The NEWDEAL K-WIRE is available in four different designs, with one or two sharp self-dril The NEWDEAL K-WIRE is available in four different designs, with one or two sharp self-drilling tips either smooth or partially threaded. One part is fixed on a standard surgical power tool equipment for insertion. They are made out of stainless steel and are dedicated to fixation of bone fractures, bone reconstruction, as guide pins for insertion of other implants.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

115110ND

Brand Name

K-WIRE

Version/Model Number

115110ND

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K022599

Product Code Details

Product Code

HTY

Product Code Name

PIN, FIXATION, SMOOTH

Device Record Status

Public Device Record Key

5dacde4f-27e6-4950-b75f-fbdb7cfbb339

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 09, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NEWDEAL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 388
2 A medical device with a moderate to high risk that requires special controls. 235