Duns Number:238476068
Device Description: Hemostatic Granules: the device is indicated for the local management of bleeding such as Hemostatic Granules: the device is indicated for the local management of bleeding such as lacerations, minor cuts and abrasions. The device is for temporary external use only.
Catalog Number
FG08830441
Brand Name
CELOX Granules
Version/Model Number
FG08830441
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
a2de8ec5-0f78-45b0-bf84-e57b67710e54
Public Version Date
March 10, 2021
Public Version Number
2
DI Record Publish Date
September 23, 2020
Package DI Number
75060206630658
Quantity per Package
200
Contains DI Package
15060206630656
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 |