Catalog Number

115425

Brand Name

K-WIRE

Version/Model Number

115425ND

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

HTY

Product Code Name

PIN, FIXATION, SMOOTH

Public Device Record Key

0ec76b88-1c1a-48e0-8f95-b71267991802

Public Version Date

November 16, 2018

Public Version Number

1

DI Record Publish Date

October 16, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-