Duns Number:801380697
Device Description: The Hemostasis NexFoam topical hemostat sponge is a sterile, topical wound dressing compri The Hemostasis NexFoam topical hemostat sponge is a sterile, topical wound dressing comprised of plant based polysaccharides. The hemostatic particles quickly dehydrate blood cells, resulting in hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding.
Catalog Number
-
Brand Name
NexFoam
Version/Model Number
9110254
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
K102459,K102459
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
73e1df45-0a95-409a-86c7-bdb3bf2a43c1
Public Version Date
October 08, 2020
Public Version Number
1
DI Record Publish Date
September 30, 2020
Package DI Number
00858439001606
Quantity per Package
5
Contains DI Package
00858439001453
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 | 9 |
| U | Unclassified | 7 |