Duns Number:238476068
Device Description: Hemostatic Gauze. The device is indicated for: Temporary external treatment to control mod Hemostatic Gauze. The device is indicated for: Temporary external treatment to control moderate to severe bleeding Temporary topical dressing for bleeding control associated with minor wounds including control of minor external bleeding and exudate from sutures and/or surgical procedures.Hemostatic gauze is for temporary external use only
Catalog Number
FG07734331
Brand Name
Omni-stat Hemostatic Gauze
Version/Model Number
FG07734331
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
802d279c-0ea5-44b8-81ae-04de5d2040e2
Public Version Date
March 10, 2021
Public Version Number
2
DI Record Publish Date
January 17, 2020
Package DI Number
75060206630597
Quantity per Package
10
Contains DI Package
35060206630599
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper Case
| 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 |