Identity
- Trade Name
- NexFoam FDA UDI
- Generic Name
- Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 9110254 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858439001453 FDA UDI
- 510(k) Number
- K102459 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 1.9 Inch FDA UDIWidth — 0.6 Inch FDA UDI
Category: Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial
NexFoam by Hemostasis, LLC — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K102459 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Hemostasis, LLC
Sources (1)
- FDA UDI 73e1df45-0a95-409a-86c7-bdb3bf2a43c1 37 fields · synced May 30, 2026