Duns Number:002348191
Device Description: Pronto 035, 10F
Catalog Number
5040
Brand Name
PRONTO
Version/Model Number
IPN913541
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
DXE
Product Code Name
Catheter, embolectomy
Public Device Record Key
b12e0647-96a6-4d1e-a72b-cca732fa38b9
Public Version Date
August 05, 2022
Public Version Number
3
DI Record Publish Date
January 22, 2019
Package DI Number
30841156100333
Quantity per Package
1
Contains DI Package
10841156100339
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |