Duns Number:238476068
Device Description: Hemostatic Z-Fold Gauze - indicated for temporary external use to control bleeding of lace Hemostatic Z-Fold Gauze - indicated for temporary external use to control bleeding of lacerations, minor cuts and abrasions
Catalog Number
30-212
Brand Name
CELOX Rapid Z-fold Gauze - B-Con
Version/Model Number
FG05839151
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)
-
Over the Counter (OTC)
Yes
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
554c542a-a4ad-40c3-8e2a-615178a4834f
Public Version Date
April 08, 2021
Public Version Number
1
DI Record Publish Date
March 31, 2021
Package DI Number
75060206630856
Quantity per Package
200
Contains DI Package
15060206630854
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 |