Duns Number:397310355
Device Description: An adhesive lipido-colloid foam dressing with soft-adherent TLC and silicone border.Compos An adhesive lipido-colloid foam dressing with soft-adherent TLC and silicone border.Composed of:- a soft-adherent TLC layer combined with an absorbent polyurethane foam pad and a superabsorbent layer- a vapour permeable waterproof outer film with silicone adhesive on the edges
Catalog Number
-
Brand Name
URGOTUL ABSORB BORDER
Version/Model Number
550762
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAD
Product Code Name
Dressing, Wound, Occlusive
Public Device Record Key
4d91ed8b-94b9-4289-9b20-4cc465c1c8af
Public Version Date
October 06, 2021
Public Version Number
2
DI Record Publish Date
April 26, 2021
Package DI Number
03546890028535
Quantity per Package
10
Contains DI Package
03546890035144
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| U | Unclassified | 5 |