Catalog Number

101902

Brand Name

ILIZAROV SYSTEMS

Version/Model Number

101902

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"

-

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

K994143

Product Code

JDW

Product Code Name

PIN, FIXATION, THREADED

Public Device Record Key

9577c1c2-cdb5-4bcf-9461-70cf16e0ec25

Public Version Date

November 23, 2021

Public Version Number

4

DI Record Publish Date

September 30, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-