Duns Number:238476068
Device Description: Hemostatic Gauze: The device is indicated for temporary external use to control bleeding o Hemostatic Gauze: The device is indicated for temporary external use to control bleeding of lacerations, minor cuts and abrasions. Hemostatic gauze is for temporary external use only.
Catalog Number
FG08834321
Brand Name
CELOX First Aid
Version/Model Number
FG08834321
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
1ebd38d0-7b08-4637-ba90-d4da8c802f08
Public Version Date
May 20, 2022
Public Version Number
3
DI Record Publish Date
May 28, 2020
Package DI Number
35060206630261
Quantity per Package
10
Contains DI Package
15060206630267
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 |