Duns Number:963905539
Device Description: ASSIST Silver is a sterile, single use antimicrobial wound contact layer. The dressing is ASSIST Silver is a sterile, single use antimicrobial wound contact layer. The dressing is a multicomponent substrate with a low adherent wound contact surface laminated to a polyester/nylon fabric coated with an ion-exchange silver. ASSIST Silver dressings provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing. ASSIST Silver is indicated for the management of acute and chronic wounds: partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and stage I-IV dermal ulcers (vascular, venous, pressure, and diabetic). The dressings are contraindicated for patients with a known silver sensitivity. The dressing is white and the nylon side (side placed away from the wound) is printed with navy. The navy print is a circle logo with"Milliken" above and "ASSIST Silver" printed inside. The dressing is also printed with navy "this side away from wound." Dressing is perforated to allow passage of thick exudate.
Catalog Number
3000119465
Brand Name
ASSIST Silver
Version/Model Number
Perforated 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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K103141,K103141,K103141
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
60a20435-6d42-4422-9859-73cdea46ef0b
Public Version Date
February 10, 2021
Public Version Number
1
DI Record Publish Date
February 02, 2021
Package DI Number
10015961681493
Quantity per Package
10
Contains DI Package
00015961681496
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelf box
| 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 |