Duns Number:002397347
Device Description: Actreen® Hi-Lite Cath Coude Set 37cm 16 Fr
Catalog Number
242116NA
Brand Name
Actreen®
Version/Model Number
242116NA
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
GBM
Product Code Name
CATHETER, URETHRAL
Public Device Record Key
ba015648-08aa-4af7-ab81-f1170cf2665f
Public Version Date
December 10, 2021
Public Version Number
3
DI Record Publish Date
March 03, 2019
Package DI Number
04046955196579
Quantity per Package
14
Contains DI Package
04046955196562
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 277 |
| U | Unclassified | 2 |