Duns Number:238476068
Device Description: Hemostatic Granules in an Applicator - Indicated for Temporary traumatic wound treatment t Hemostatic Granules in an Applicator - Indicated for Temporary traumatic wound treatment to control moderate to severe bleeding. For temporary external use only
Catalog Number
30-235
Brand Name
CELOX- A CMS
Version/Model Number
FG05832101
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
78f3e72c-76b1-48fa-8563-e878e9f1dcfb
Public Version Date
August 09, 2021
Public Version Number
1
DI Record Publish Date
July 31, 2021
Package DI Number
35060206630865
Quantity per Package
10
Contains DI Package
15060206630861
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner 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 |