Duns Number:926346966
Catalog Number
402839
Brand Name
Safire™ TX
Version/Model Number
402839
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
P040042
Product Code
OAD
Product Code Name
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Public Device Record Key
5138558c-faa8-4350-be35-f6aa6d9fc3f3
Public Version Date
January 28, 2019
Public Version Number
3
DI Record Publish Date
September 29, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 129 |
3 | A medical device with high risk that requires premarket approval | 75 |