Duns Number:431406875
Device Description: End cap for femoral nail.Lenght: Standard cap + 15 mm.Material: titanium alloy Ti6Al4V ELI End cap for femoral nail.Lenght: Standard cap + 15 mm.Material: titanium alloy Ti6Al4V ELI (ASTM F136).
Catalog Number
EBA-6015
Brand Name
EBA2
Version/Model Number
End cap + 15 mm
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
fc77dc51-e21a-4311-8687-b607243e0785
Public Version Date
April 07, 2021
Public Version Number
5
DI Record Publish Date
August 05, 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 |