Duns Number:006133784
Device Description: CRYO CART KIT ASSEMBLY - TWO TANK SUPPORTS
Catalog Number
A000843
Brand Name
AtriCure System Cart
Version/Model Number
ASCC2
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HMF
Product Code Name
Stand, Instrument, Ac-Powered, Ophthalmic
Public Device Record Key
53ac2ab5-6927-408e-84a0-4aa61cba3d03
Public Version Date
January 19, 2021
Public Version Number
1
DI Record Publish Date
January 11, 2021
Package DI Number
30840143902127
Quantity per Package
1
Contains DI Package
10840143904035
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 129 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 133 |
| 3 | A medical device with high risk that requires premarket approval | 11 |