Duns Number:016898496
Device Description: Aurora Condomcatheter Met Hydrocolloide Kleefzone
Catalog Number
SU303
Brand Name
Aurora Hydrocolloide Adhesive Sheath
Version/Model Number
SU303
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NNX
Product Code Name
DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
Public Device Record Key
db1865f7-2868-4dab-9c36-d47536f2b2b9
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
September 22, 2020
Package DI Number
10801741072038
Quantity per Package
30
Contains DI Package
00801741072031
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 472 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1994 |
| U | Unclassified | 10 |