Duns Number:238476068
Device Description: Hemostatic Z-fold Gauze. Dressing is indicated to control moderate to severe bleeding. For Hemostatic Z-fold Gauze. Dressing is indicated to control moderate to severe bleeding. For emergency temporary external use. For use by trained emergency responders. Chito-R technology
Catalog Number
FG08839061
Brand Name
CELOX Rapid
Version/Model Number
FG08839061
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
6f7e3c1b-f960-402b-97f5-17e7aa6b792b
Public Version Date
June 08, 2021
Public Version Number
1
DI Record Publish Date
May 31, 2021
Package DI Number
75060206630603
Quantity per Package
200
Contains DI Package
15060206630601
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 |