Duns Number:079290879
Device Description: The POWERWAND XL-REC Introducer with Extended Dwell Catheter. *Power Injectable. *ZERO-EDG The POWERWAND XL-REC Introducer with Extended Dwell Catheter. *Power Injectable. *ZERO-EDGE transitions. *Radiopaque
Catalog Number
95001
Brand Name
POWERWAND™ XL-REC
Version/Model Number
4Fr x 6cm
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"
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
K131300,K131300,K131300
Product Code
DYB
Product Code Name
Introducer, Catheter
Public Device Record Key
4f373b04-0b9f-4bb1-81d5-ef8a774cc1f6
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 30, 2017
Package DI Number
30859821006514
Quantity per Package
12
Contains DI Package
20859821006517
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Overpack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 59 |