Duns Number:964569052
Device Description: Armada 18 PTA Catheter 2.5 mm x 200 mm x 150 cm / Over-The-Wire
Catalog Number
1013464-200
Brand Name
Armada
Version/Model Number
1013464-200
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
-
Product Code
LIT
Product Code Name
Catheter, angioplasty, peripheral, transluminal
Public Device Record Key
5c1a87fd-3a74-4802-9928-f21efa8c8019
Public Version Date
August 09, 2019
Public Version Number
4
DI Record Publish Date
January 15, 2016
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 964 |
| 3 | A medical device with high risk that requires premarket approval | 775 |