Duns Number:434581062
Device Description: 5MM DIA X 180MM LENGTH HALF PIN ST. STEEL STANDARD TIP
Catalog Number
71012502
Brand Name
ILIZAROV SYSTEMS
Version/Model Number
71012502
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
e14ac476-6456-469b-be58-7377bbc3baf4
Public Version Date
August 24, 2018
Public Version Number
4
DI Record Publish Date
November 01, 2016
Package DI Number
28033201842410
Quantity per Package
5
Contains DI Package
08033201842416
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |