Duns Number:238476068
Device Description: Hemostatic Granules. For minor external bleeding from wounds and procedures the device is Hemostatic Granules. For minor external bleeding from wounds and procedures the device is indicated for use as a temporary topical dressing for bleeding control associated with minor wounds, including control of minor external bleeding and exudate from sutures and/or surgical procedures. For moderate to severe external bleeding wounds the device is indicated for temporary external treatment for controlling moderate to severe bleeding.
Catalog Number
FG07730591
Brand Name
Omni-stat Granules
Version/Model Number
FG07730591
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
-
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
42079cfd-e596-41ce-a16c-9d5e5ba44684
Public Version Date
March 10, 2021
Public Version Number
2
DI Record Publish Date
December 03, 2019
Package DI Number
35060206630582
Quantity per Package
10
Contains DI Package
15060206630588
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelf Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| U | Unclassified | 14 |