Duns Number:005235436
Device Description: Superion Cannula
Catalog Number
100-9137
Brand Name
Superion Cannula
Version/Model Number
N/A
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 17, 2020
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
-
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
NQO
Product Code Name
Prosthesis, Spinous Process Spacer/Plate
Public Device Record Key
8b4ad8e4-ce65-4a19-a857-75457637903c
Public Version Date
October 05, 2020
Public Version Number
5
DI Record Publish Date
August 16, 2017
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 |
---|---|---|
3 | A medical device with high risk that requires premarket approval | 18 |