Duns Number:238476068
Device Description: Hemostatic Z-Fold Gauze - indicated to control moderate to severe bleeding. For emergency Hemostatic Z-Fold Gauze - indicated to control moderate to severe bleeding. For emergency temporary external use only.
Catalog Number
30-223
Brand Name
CELOX Rapid Ribbon - CMS
Version/Model Number
FG05839141
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
08d55641-4b61-4608-8add-fd6450293d90
Public Version Date
August 09, 2021
Public Version Number
1
DI Record Publish Date
July 31, 2021
Package DI Number
75060206630849
Quantity per Package
150
Contains DI Package
15060206630847
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 |