Duns Number:052758618
Device Description: A soft-adherent lipido-colloid foam dressing consisting of a coating on a polyurethane pad A soft-adherent lipido-colloid foam dressing consisting of a coating on a polyurethane pad with a micro-adherent lipido-colloid matrix with a vapor permeable waterproof outer film with silicone adhesive on the edges.
Catalog Number
550762
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
ff53bfe6-af64-48d8-a866-621f24e08855
Public Version Date
July 22, 2021
Public Version Number
5
DI Record Publish Date
March 01, 2019
Package DI Number
10190769507623
Quantity per Package
24
Contains DI Package
00190769507626
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 | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 12 |