Duns Number:052758618
Device Description: Contact Layer Silver is a non-adhesive, non-occlusive, antimicrobial wound contact dressin Contact Layer Silver is a non-adhesive, non-occlusive, antimicrobial wound contact dressing, composed of a polyester mesh impregnated with a matrix of hydrocolloid particles (carboxymethylcellulose), cohesion polymers, petrolatum and silver. Not made with natural rubber.
Catalog Number
553228
Brand Name
UrgoTul Ag/Silver
Version/Model Number
553228
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
458c059a-a23e-4d15-98c3-926cec4092fc
Public Version Date
September 11, 2020
Public Version Number
3
DI Record Publish Date
February 03, 2020
Package DI Number
10190769532281
Quantity per Package
5
Contains DI Package
00190769532284
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| 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 |