Duns Number:042075700
Device Description: The StatGuard Hemostatic Dressing is composed of a non-woven gauze made of chitosan which The StatGuard Hemostatic Dressing is composed of a non-woven gauze made of chitosan which is applied to an arterial or venous puncture or incision to promote post-procedure hemostasis and control of moderate to severe wound bleeding, exudates absorption, and coagulation. Model 3020-10 provides a 2 cm x 3.5 cm gauze, in an 8 cm x 10 cm adhesive dressing
Catalog Number
480-3020-20
Brand Name
StatGuard Hemostatic Dressing, Regular
Version/Model Number
3020-20
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
d24083d9-aff6-4ed5-8680-c07deb7ef18b
Public Version Date
March 10, 2021
Public Version Number
3
DI Record Publish Date
February 28, 2019
Package DI Number
20815614020825
Quantity per Package
20
Contains DI Package
10815614020828
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |