Duns Number:052758618
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 particles dispersed in a petroleum jelly matrix.
Catalog Number
506488
Brand Name
UrgoTul
Version/Model Number
506488
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
86d67487-28b6-4675-84bb-c92582db6599
Public Version Date
July 22, 2021
Public Version Number
5
DI Record Publish Date
March 01, 2019
Package DI Number
10190769064881
Quantity per Package
16
Contains DI Package
00190769064884
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 |