Duns Number:434581062
Device Description: 1.8 MM DIA 370 MM LENGTH ST. STEEL ILIZAROV WIRE CORTICAL, BAYONET POINT
Catalog Number
102102
Brand Name
ILIZAROV SYSTEMS
Version/Model Number
102102
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
21706da6-357d-4b4f-91ac-cd4dc78cd9a7
Public Version Date
August 30, 2018
Public Version Number
4
DI Record Publish Date
October 27, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 86 |