Duns Number:431406875
Device Description: Kit composed of:- Femoral nail L360mm (1 pc);- Guide wire (1 pc);- End cap (1 pc).Nail mat Kit composed of:- Femoral nail L360mm (1 pc);- Guide wire (1 pc);- End cap (1 pc).Nail material: titanium alloy Ti6Al4V ELI (ASTM F136).
Catalog Number
EBA-1800
Brand Name
ENDOVIS B.A.
Version/Model Number
Long nail L360mm, 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
K113387
Product Code
HSB
Product Code Name
Rod, Fixation, Intramedullary And Accessories
Public Device Record Key
4b5d7f1b-8ca2-4ff4-9a4a-034da9223071
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 21, 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 | 112 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1181 |