Duns Number:238476068
Device Description: Hemostatic Gauze: The device is indicated for: Temporary external treatment for controllin Hemostatic Gauze: The device is indicated for: Temporary external treatment for controlling 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
FG04534191
Brand Name
OMNI-STAT Hemostatic Gauze
Version/Model Number
FG04534191
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
89e6359a-037a-4065-bac0-0bf83301ce62
Public Version Date
March 10, 2021
Public Version Number
2
DI Record Publish Date
May 28, 2020
Package DI Number
35060206630629
Quantity per Package
10
Contains DI Package
15060206630625
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 |