Duns Number:431406875
Device Description: Kit composed of:- Right Nail ø13mm L380mm (1 pc);- Guide wire (1 pc).Material of the nail: Kit composed of:- Right Nail ø13mm L380mm (1 pc);- Guide wire (1 pc).Material of the nail: titanium alloy Ti6Al4V ELI (ASTM F136).
Catalog Number
EBA-661338
Brand Name
EBA2
Version/Model Number
Long nail ø13mm L380mm, right
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
K131005
Product Code
HSB
Product Code Name
Rod, Fixation, Intramedullary And Accessories
Public Device Record Key
94173299-1582-4fc1-b904-1f09330658ca
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 12, 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 | 112 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1181 |