Duns Number:006261481
Device Description: KIT 20MRK ARCTIC FRNT MANETRACT GLB ROHS
Catalog Number
-
Brand Name
NA
Version/Model Number
20MRK
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
P100010
Product Code
OAE
Product Code Name
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Public Device Record Key
7292875b-4cc7-4b9c-b6bc-59b2898da9dc
Public Version Date
May 06, 2020
Public Version Number
5
DI Record Publish Date
May 08, 2015
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 | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |