Duns Number:305524696
Device Description: Skin Barrier Wipe
Catalog Number
0925
Brand Name
COLOPLAST PREP
Version/Model Number
0925
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
NEC
Product Code Name
Bandage, liquid, skin protectant
Public Device Record Key
ec2bdafa-c674-48d3-9e1f-50d898a07f54
Public Version Date
May 02, 2022
Public Version Number
1
DI Record Publish Date
April 22, 2022
Package DI Number
00311701007930
Quantity per Package
1
Contains DI Package
00311701007039
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper 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 |