Duns Number:600041570
Device Description: WoundClot hemostatic gauze is based on cellulosic structure. In contact with liquids it fo WoundClot hemostatic gauze is based on cellulosic structure. In contact with liquids it forms absorbent gel which adheres to the wound surface to control bleeding.WoundClot is hemostatic gauze for emergency and therapeutic use in the control of bleeding from the skin and other surface wounds where temporary control of bleeding is required, including traumatic bleeding.
Catalog Number
101411901
Brand Name
WoundClot Hemostatic Gauze
Version/Model Number
4"X4" EMS 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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K140573,K140573
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
8cc98034-4b9c-42cf-b58a-4c556e59ba3f
Public Version Date
September 09, 2021
Public Version Number
1
DI Record Publish Date
September 01, 2021
Package DI Number
17290016339182
Quantity per Package
10
Contains DI Package
07290016339185
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| U | Unclassified | 17 |