Duns Number:238476068
Device Description: Hemostatic Gauze: Hemostatic gauze dressing coated with Celox Granules. Device is indicate Hemostatic Gauze: Hemostatic gauze dressing coated with Celox Granules. Device is indicated for temporary external use to control bleeding of lacerations, minor cuts, and abrasions.
Catalog Number
FG08834041
Brand Name
CELOX First Aid
Version/Model Number
FG08834041
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
95a03acf-8d8b-4ab1-b47a-6d82cbe708e0
Public Version Date
May 20, 2022
Public Version Number
3
DI Record Publish Date
September 23, 2020
Package DI Number
75060206630665
Quantity per Package
50
Contains DI Package
15060206630663
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 |