Duns Number:305524696
Device Description: ELEFANT® Suction-irrigation device without connection tube, diameter 5mm, length 350mm
Catalog Number
ASP145
Brand Name
Porges Coloplast
Version/Model Number
ASP145
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
-
Product Code
FQH
Product Code Name
LAVAGE, JET
Public Device Record Key
14b0c2c2-a066-4c74-a92b-f74989c3c567
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 01, 2016
Package DI Number
03600040210468
Quantity per Package
10
Contains DI Package
03600040210451
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Retail box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 46 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 899 |
| 3 | A medical device with high risk that requires premarket approval | 72 |
| U | Unclassified | 7 |