Duns Number:397310355
Device Description: A non-occlusive semi-permeable absorbent dressing impregnated with Silver Salts derived fr A non-occlusive semi-permeable absorbent dressing impregnated with Silver Salts derived from Technology Lipido-Colloid (TLC). Composed of 3 layers :- Silver Healing Matrix TLC-Ag made of polyester mesh impregnated with hydrocolloid particles (carboxymethylcellulose), vaseline, cohesion polymers and Silver salts- an absorbent polyurethane foam pad- a protective polyurethane backing
Catalog Number
-
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
3f754d17-777c-4020-bacb-c92d7275384d
Public Version Date
October 06, 2021
Public Version Number
2
DI Record Publish Date
April 26, 2021
Package DI Number
03546890028597
Quantity per Package
10
Contains DI Package
03546890035250
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 |