Duns Number:397310355
Device Description: A soft-adherent lipido-colloid foam dressing with TLC.Composed of:- a soft-adherent TLC la A soft-adherent lipido-colloid foam dressing with TLC.Composed of:- a soft-adherent TLC layer made up of polymers and hydrocolloid particles combined with an absorbent polyurethane foam pad - and a protective non-woven polyurethane backing.
Catalog Number
-
Brand Name
URGOTUL ABSORB
Version/Model Number
509382
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
810f736f-0025-4d54-be64-7ee4781192e1
Public Version Date
October 06, 2021
Public Version Number
2
DI Record Publish Date
April 26, 2021
Package DI Number
03546890028559
Quantity per Package
10
Contains DI Package
03546890035175
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 |