Duns Number:109903521
Device Description: ILIZAROV CABLE 3.5MM LOOP 1.0 X 1200MM
Catalog Number
76522006
Brand Name
ILIZAROV SYSTEMS
Version/Model Number
76522006
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 02, 2018
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
K042436
Product Code
KTT
Product Code Name
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Public Device Record Key
5c86f6dd-5109-4d36-ab04-1d8bc729e3cc
Public Version Date
November 23, 2021
Public Version Number
4
DI Record Publish Date
August 29, 2015
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 | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |