Duns Number:964569052
Device Description: RX ACCUNET Embolic Protection System 4.5/300 Rapid-Exchange
Catalog Number
1011650-45
Brand Name
Accunet
Version/Model Number
1011650-45
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
-
Product Code
NTE
Product Code Name
Temporary Carotid Catheter for Embolic Capture
Public Device Record Key
ae300aaa-082d-47b3-a652-0e9f2aaccd46
Public Version Date
April 09, 2019
Public Version Number
3
DI Record Publish Date
February 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 964 |
| 3 | A medical device with high risk that requires premarket approval | 775 |