Catalog Number

100601

Brand Name

ILIZAROV SYSTEMS

Version/Model Number

100601

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,K994143

Product Code

JDW

Product Code Name

PIN, FIXATION, THREADED

Public Device Record Key

f2e80fc8-7bfb-4f23-872f-219a14ed57a5

Public Version Date

November 23, 2021

Public Version Number

4

DI Record Publish Date

September 30, 2016

Package DI Number

28033201841000

Quantity per Package

5

Contains DI Package

08033201841006

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX