Duns Number:052758618
Device Description: A non-adhesive, non-occlusive antimicrobial wound contact dress composed of a polyester me A non-adhesive, non-occlusive antimicrobial wound contact dress composed of a polyester mesh impregnated with a matrix comprising of hydrocolloid particles (carboxymethycellulose), cohesion polymers, petrolatum and silver.
Catalog Number
509341
Brand Name
UrgoTul Ag/Silver
Version/Model Number
509341
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
fde7e86c-d905-4bcc-93a9-5a6292dbaec9
Public Version Date
September 11, 2020
Public Version Number
5
DI Record Publish Date
March 01, 2019
Package DI Number
10190769093416
Quantity per Package
16
Contains DI Package
00190769093419
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 |