Duns Number:397310355
Device Description: A non-occlusive flexible and conformable dressing comprising of a polyester mesh impregnat A non-occlusive flexible and conformable dressing comprising of a polyester mesh impregnated with hydrocolloid particledispersed in a petroleum jelly matrix.
Catalog Number
-
Brand Name
URGOTUL
Version/Model Number
506487
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
NAC
Product Code Name
Dressing, Wound, Hydrophilic
Public Device Record Key
be3ba4f7-ae56-45de-ba9d-fad2789bc5a6
Public Version Date
October 06, 2021
Public Version Number
2
DI Record Publish Date
May 05, 2021
Package DI Number
03546890028641
Quantity per Package
10
Contains DI Package
03546890035236
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 |