Duns Number:052758618
Device Description: Drawtex Hydroconductive Wound Dressing with LevaFiber 8X8 (1 bx of 10 dressings) is a nonm Drawtex Hydroconductive Wound Dressing with LevaFiber 8X8 (1 bx of 10 dressings) is a nonmedicated dressing made up of natural and synthetic fibers: viscose, cotton and polyester. It is for the management of acute wounds, including complex surgical wounds and burns (first and second degree) and management of chronic wounds including leg ulcers, diabetic foot ulcers and pressure ulcers (stages II - IV).
Catalog Number
00304
Brand Name
Drawtex Hydroconductive Wound Dressing with LevaFiber 8X8
Version/Model Number
00304
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAC
Product Code Name
Dressing, Wound, Hydrophilic
Public Device Record Key
ee2d4258-2dae-4998-a330-2cc6dc81cc6c
Public Version Date
January 26, 2022
Public Version Number
3
DI Record Publish Date
November 01, 2019
Package DI Number
10851383003044
Quantity per Package
10
Contains DI Package
00851383003047
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| 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 |