Duns Number:052758618
Device Description: A non-adhesive, non-occlusive, antimicrobial absorbent dressing composed of 1) a polyester A non-adhesive, non-occlusive, antimicrobial absorbent dressing composed of 1) a polyester mesh impregnated with a matrix comprising of hydrocolloid particle (carboxymethylcellulose), cohesiopolymers, petrolatum and silver sulfate, 2) a non-sensitizing, super absorbent polyurethane foam pad, 3) a protective, semi-permeable polyurethane foam backing.
Catalog Number
509345
Brand Name
UrgoCell Ag/Silver
Version/Model Number
509345
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
485da380-c95f-4ba1-81aa-161c7eb6cb6a
Public Version Date
September 11, 2020
Public Version Number
5
DI Record Publish Date
March 01, 2019
Package DI Number
10190769093454
Quantity per Package
12
Contains DI Package
00190769093457
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 |