Duns Number:067584601
Device Description: CL MI Reduction Tray
Catalog Number
80-4973
Brand Name
CorticaLINK MI
Version/Model Number
80-4973
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
-
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
LRP
Product Code Name
Tray, Surgical
Public Device Record Key
fcc8305a-9943-4562-a54c-ba83ba7043e3
Public Version Date
November 22, 2018
Public Version Number
2
DI Record Publish Date
July 06, 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 | 242 |
2 | A medical device with a moderate to high risk that requires special controls. | 337 |
U | Unclassified | 12 |