Duns Number:238476068
Device Description: Haemostatic Granules in Applicator. Applicator containing 6g haemostatic granules. The dev Haemostatic Granules in Applicator. Applicator containing 6g haemostatic granules. The device is indicated for temporary traumatic wound treatment to control moderate to severe bleeding.
Catalog Number
FG08832071
Brand Name
CELOX A
Version/Model Number
FG08832071
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"
Yes
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
94e26dbd-5c60-439e-826b-8ac492ebe8cb
Public Version Date
March 10, 2021
Public Version Number
2
DI Record Publish Date
January 29, 2021
Package DI Number
35060206630018
Quantity per Package
10
Contains DI Package
15060206630014
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Shipper
| 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 |