Duns Number:482661753
Device Description: PROWLER PLUS Infusion Catheter with 2 Markers Infusion Catheter 2.8F (0.95 mm) 2.3F (0.75 PROWLER PLUS Infusion Catheter with 2 Markers Infusion Catheter 2.8F (0.95 mm) 2.3F (0.75 mm) .021 Inch (.5 mm) 3cm 20 cm 150 cm J Contents: 1 Infusion Catheter and 1 Shape Mandrel. Minimum Guiding Catheter I.D. / Dia. .042 Inch (1.1 mm)
Catalog Number
6062510JX
Brand Name
PROWLER
Version/Model Number
606-2510JX
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
K003925,K993266
Product Code
KRA
Product Code Name
Catheter, continuous flush
Public Device Record Key
b6e8d94a-469b-441c-a21c-07e6e36af3bc
Public Version Date
March 04, 2020
Public Version Number
6
DI Record Publish Date
June 30, 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 | 972 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6382 |
| 3 | A medical device with high risk that requires premarket approval | 20 |
| U | Unclassified | 20 |