Catalog Number
LS-168
Brand Name
Excella II®
Version/Model Number
LS-168
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
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
-
Product Code
HWX
Product Code Name
Tap, Bone
Public Device Record Key
a92d6f18-a7a3-49f2-a2d5-a6c5ad18313a
Public Version Date
September 07, 2018
Public Version Number
1
DI Record Publish Date
August 07, 2018
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 | 252 |
2 | A medical device with a moderate to high risk that requires special controls. | 2102 |