Duns Number:238476068
Device Description: Hemostatic Gauze Pad. The device is indicated for temporary external use to control modera Hemostatic Gauze Pad. The device is indicated for temporary external use to control moderate to severe bleeding. The hemostatic gauze is for temporary external use only.
Catalog Number
FG08834281
Brand Name
CELOX EMS
Version/Model Number
FG08834281
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
a0a8f030-5e64-42bf-b0da-4d3531293d4a
Public Version Date
March 10, 2021
Public Version Number
2
DI Record Publish Date
September 23, 2020
Package DI Number
35060206630179
Quantity per Package
5
Contains DI Package
15060206630175
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 |