Duns Number:238476068
Device Description: Hemostatic Z-Fold Gauze. Dressing indicated for temporary external use to control moderate Hemostatic Z-Fold Gauze. Dressing indicated for temporary external use to control moderate to severe bleeding. For use by trained emergency responders.Chito-R Technology
Catalog Number
30-215
Brand Name
CELOX Rapid Z-Fold Gauze - MARCH CMS
Version/Model Number
FG05839071
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
0d30823a-c3a8-407e-8298-389ca25b51f0
Public Version Date
March 10, 2021
Public Version Number
2
DI Record Publish Date
January 29, 2021
Package DI Number
07500206630610
Quantity per Package
100
Contains DI Package
15060206630618
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 |