Duns Number:963905539
Device Description: ASSIST Absorbent is a sterile, single use multi-layer low-adherent absorbent wound dressin ASSIST Absorbent is a sterile, single use multi-layer low-adherent absorbent wound dressing. ASSIST 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. The dressing has a low-adherent veil wound contact layer, a polyester/ nylon wound contact layer, two layers of absorptive non-woven, and a white occlusive outer layer.
Catalog Number
3000004622
Brand Name
ASSIST Absorbent
Version/Model Number
24"x36"
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FPY
Product Code Name
Sheet, Burn
Public Device Record Key
39d76d54-a7af-452e-a2c2-b4497872eb2b
Public Version Date
February 10, 2021
Public Version Number
1
DI Record Publish Date
February 02, 2021
Package DI Number
10015961293009
Quantity per Package
25
Contains DI Package
00015961293002
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 |