Duns Number:238476068
Device Description: Hemostatic Gauze Pads: The device is indicated for: temporary external use to control mode Hemostatic Gauze Pads: The device is indicated for: temporary external use to control moderate to severe bleeding. Hemostatic gauze is for temporary external use only
Catalog Number
FG08834291
Brand Name
CELOX EMS
Version/Model Number
FG08834291
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
22f5e5c1-2932-4607-aec9-99ba52d13b46
Public Version Date
March 10, 2021
Public Version Number
2
DI Record Publish Date
September 23, 2020
Package DI Number
35060206630162
Quantity per Package
10
Contains DI Package
15060206630168
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelf Carton
| 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 |