Duns Number:238476068
Device Description: Hemostatic Z-Fold Gauze - Non-woven gauze coated with Celox hemostatic granules. The dress Hemostatic Z-Fold Gauze - Non-woven gauze coated with Celox hemostatic granules. The dressing is indicated for temporary external use to control bleeding of lacerations, minor cuts, and abrasions. For use by trained emergency responders.
Catalog Number
FG08838181
Brand Name
CELOX Gauze Z-Fold
Version/Model Number
FG08838181
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)
-
Over the Counter (OTC)
Yes
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
509785fb-c4ab-4a44-a633-0a3db40d8b96
Public Version Date
September 08, 2022
Public Version Number
1
DI Record Publish Date
August 31, 2022
Package DI Number
75060206631396
Quantity per Package
100
Contains DI Package
15060206631394
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 |