Duns Number:963905539
Device Description: ASSIST Silver Absorbent is a sterile, single use multi-layer low-adherent absorbent wound ASSIST Silver Absorbent is a sterile, single use multi-layer low-adherent absorbent wound dressing. ASSIST Silver Absorbent is indicated for management of acute and chronic wounds: partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, lymphedema, dermatological wounds, and stage I-IV vascular ulcers, pressure ulcers, venous ulcers, and diabetic ulcers. ASSIST Silver Absorbent dressings provide 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 low-adherent veil wound contact layer, a polyester/ nylon wound contact layer coated with an ion-exchange silver, two layers of absorptive non-woven, and a grey occlusive outer layer. The film outer layer (side placed away from the wound) is grey and embossed. The embossing is a circle logo with "ASSIST Silver" printed inside. The logo has "This side away from wound," embossed above and below.
Catalog Number
3000117009
Brand Name
ASSIST Silver Absorbent
Version/Model Number
Half Bed 36"x48"
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K083659,K083659
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
be887935-d04d-4249-bf41-2b941c53aa7e
Public Version Date
February 10, 2021
Public Version Number
1
DI Record Publish Date
February 02, 2021
Package DI Number
10015961668623
Quantity per Package
5
Contains DI Package
00015961668626
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 |