Duns Number:963905539
Device Description: ULTRA Silver is a sterile, single use foam wound dressing. ULTRA Silver is indicated for m ULTRA Silver is a sterile, single use foam wound dressing. ULTRA Silver is indicated for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and stage I-IV vascular ulcers, pressure ulcers, venous ulcers, and diabetic ulcers. ULTRA Silver dressings kill bacteria within the dressing and provides an antimicrobial barrier and reduces microbial penetration through the dressing. The dressing is contraindicated for patients with a known silver sensitivity. The dressing has a polyester/ nylon wound contact layer coated with an ion-exchange silver, polyurethane absorbent foam, and a moisture vapor permeable film outer layer. The film outer layer (side placed away from the wound) is tan printed with green. The print is a circle logo with "Milliken" above and "ULTRA Silver" printed inside. The dressing is also printed with "this side away from wound," as well as a repeating set of symbols of an arrow, heart, and shield.
Catalog Number
3000112212
Brand Name
ULTRA Silver
Version/Model Number
8"x20"
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"
-
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
351f3632-9407-4e79-b599-c19ee2f83b13
Public Version Date
January 14, 2021
Public Version Number
1
DI Record Publish Date
January 06, 2021
Package DI Number
20015961649704
Quantity per Package
5
Contains DI Package
10015961649707
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| U | Unclassified | 5 |