Duns Number:149818952
Device Description: Generator Kit
Catalog Number
H700494
Brand Name
Ampere™
Version/Model Number
H700494
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
P110016,P110016
Product Code
OAD
Product Code Name
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Public Device Record Key
096e6279-4b19-4b18-a5c3-5497edbf9170
Public Version Date
June 10, 2022
Public Version Number
7
DI Record Publish Date
December 03, 2014
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 | 70 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1429 |
| 3 | A medical device with high risk that requires premarket approval | 736 |