Duns Number:042075700
Device Description: The StatGuard Hemostatic Patch is composed of a non-woven gauze made of chitosan which is The StatGuard Hemostatic Patch is composed of a non-woven gauze made of chitosan which is applied to an arterial or venous puncture or incision following to promote post-procedure hemostasis and control of moderate to severe wound bleeding, exudates absorption, and coagulation.
Catalog Number
480-3010-00
Brand Name
StatGuard Hemostatic Patch
Version/Model Number
3010-00
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"
Yes
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
K172155,K172155,K172155
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
b97fc98b-4d65-402a-92c9-6e93e73c5bbb
Public Version Date
March 10, 2021
Public Version Number
3
DI Record Publish Date
August 07, 2019
Package DI Number
30815614020808
Quantity per Package
10
Contains DI Package
20815614020801
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 1 |