Duns Number:238476068
Device Description: Hemostatic Pad: The device is indicated for the local management and control of surface bl Hemostatic Pad: The device is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 16 French. The hemostatic pad is for temporary external use only.
Catalog Number
FG08834081
Brand Name
CELOX Vascular
Version/Model Number
FG08834081
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
99d9ece5-2afb-4565-9d1c-6ee3e81b3592
Public Version Date
March 10, 2021
Public Version Number
2
DI Record Publish Date
September 23, 2020
Package DI Number
35060206630643
Quantity per Package
10
Contains DI Package
15060206630649
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
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 |