Identity
- Trade Name
- SiOxD Wound Matrix FDA UDI
- Generic Name
- Synthetic wound matrix dressing FDA UDI
- Device Name
- The SiOxD Wound Matrix is a non-pyrogenic, sterile, single use device intended for use in local management of wounds. The SiOxD Wound Matrix is a soft, white, conformable, non-woven, absorbent, biocompatible fiber matrix made from synthetic biomaterials. The SiOxD Wound Matrix conforms in the defect space / wound bed and includes a fibrous, porous structure that allows for fluid absorption. The SiOxD Wound Matrix is structurally similar to collagen, a key component of the native extracellular matrix, and serves as a scaffold for cellular infiltration and vascularization. SiOxD Wound Matrix promotes a moist environment for the body’s natural healing process. FDA UDI
- Model / Reference
- EDS-10058 FDA UDI
- Description
- The SiOxD Wound Matrix is a non-pyrogenic, sterile, single use device intended for use in local management of wounds. The SiOxD Wound Matrix is a soft, white, conformable, non-woven, absorbent, biocompatible fiber matrix made from synthetic biomaterials. The SiOxD Wound Matrix conforms in the defect space / wound bed and includes a fibrous, porous structure that allows for fluid absorption. The SiOxD Wound Matrix is structurally similar to collagen, a key component of the native extracellular matrix, and serves as a scaffold for cellular infiltration and vascularization. SiOxD Wound Matrix promotes a moist environment for the body’s natural healing process. FDA UDI
Identifiers
- Catalog Number
- EDS-10058 FDA UDI
- Primary DI / UDI-DI
- 10850021883000 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Synthetic wound matrix dressing 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
Category: Synthetic wound matrix dressing
SiOxD Wound Matrix by Sioxmed, LLC — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Synthetic wound matrix dressing.
- Suprathel® — Polymedics Innovations, Inc. · U
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- NovoSorb BTM — Polynovo Biomaterials Pty, Ltd. · U
- MIRRASURG™ — ETS WOUND CARE LLC · U
- Suprathel® — Polymedics Innovations, Inc. · U
- Suprathel® — Polymedics Innovations, Inc. · U
- MIRRAGEN® Advanced Wound Matrix — ETS WOUND CARE LLC · U
- Suprathel® CW — Polymedics Innovations, Inc. · U
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
- Sioxmed, LLC
Sources (1)
- FDA UDI e5ba29c8-c6ac-4ffe-a966-3cb157f52632 35 fields · synced May 30, 2026