Duns Number:600041570
Device Description: WoundClot is a soluble dressing, based on cellulosic structure. In contact with liquids it WoundClot is a soluble dressing, based on cellulosic structure. In contact with liquids it forms absorbent gel which adheres to the wound surface to control bleeding.WoundClot is intended to be used as a topical dressing for minor skin surface bleeding wounds such as minor cuts and minor abrasions.
Catalog Number
101582901
Brand Name
WoundClot Hemostatic Gauze
Version/Model Number
3"X8" OTC FDA
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K160679,K160679
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
e0eefde3-8429-4618-ac62-a584a335482d
Public Version Date
September 09, 2021
Public Version Number
1
DI Record Publish Date
September 01, 2021
Package DI Number
17290016339403
Quantity per Package
10
Contains DI Package
07290016339406
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| U | Unclassified | 17 |