Duns Number:006133784
Device Description: AtriClip FLEX•V device 40
Catalog Number
A001018
Brand Name
AtriClip FLEX•V
Version/Model Number
ACHV40
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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"
Yes
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
FZP
Product Code Name
Clip, Implantable
Public Device Record Key
100aa7e5-881c-40f1-933e-e45e369a4bd3
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
January 08, 2021
Package DI Number
30840143900147
Quantity per Package
1
Contains DI Package
10840143900143
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 |