Identity
- Trade Name
- NovoSorb SynPath FDA UDI
- Generic Name
- Synthetic wound matrix dressing FDA UDI
- Device Name
- NovoSorb® SynPath™ is a synthetic, acellular, dermal matrix made from the proprietary NovoSorb® technology that supports the adherence and proliferation of the vital cells involved in new tissue regeneration. NovoSorb® SynPath™ is a non-toxic, porous network of biodegradable synthetic polymers that act as a support template for cellular repair. The matrix is fenestrated to allow excess exudate from the wound to pass through to a secondary absorbent layer to prevent maceration. As the matrix integrates into the wound bed, it supports the creation of a neodermal structure. FDA UDI
- Model / Reference
- SYN-0202 FDA UDI
- Description
- NovoSorb® SynPath™ is a synthetic, acellular, dermal matrix made from the proprietary NovoSorb® technology that supports the adherence and proliferation of the vital cells involved in new tissue regeneration. NovoSorb® SynPath™ is a non-toxic, porous network of biodegradable synthetic polymers that act as a support template for cellular repair. The matrix is fenestrated to allow excess exudate from the wound to pass through to a secondary absorbent layer to prevent maceration. As the matrix integrates into the wound bed, it supports the creation of a neodermal structure. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09349155001229 FDA UDI
- 510(k) Number
- K172140 FDA UDI
- FDA Product Code
- QSZ 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
Dimensions & Sizes
- Size
- Length — 2 Centimeter FDA UDIWidth — 2 Centimeter FDA UDI
Category: Synthetic wound matrix dressing
NovoSorb SynPath by Polynovo Biomaterials Pty, Ltd. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Synthetic wound matrix dressing.
- SiOxD Wound Matrix — Sioxmed, LLC · U
- Suprathel® — Polymedics Innovations, Inc. · 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
- MIRRAGEN® Advanced Wound Matrix — ETS WOUND CARE LLC · U
Cleared under the same submission
K172140 also covers:
- NovoSorb BTM — Polynovo Biomaterials Pty, Ltd.
- NovoSorb BTM — Polynovo Biomaterials Pty, Ltd.
- NovoSorb BTM — Polynovo Biomaterials Pty, Ltd.
- NovoSorb BTM — Polynovo Biomaterials Pty, Ltd.
- NovoSorb SynPath — Polynovo Biomaterials Pty, Ltd.
- NovoSorb SynPath — Polynovo Biomaterials Pty, Ltd.
- NovoSorb SynPath — Polynovo Biomaterials Pty, Ltd.
- NovoSorb SynPath — Polynovo Biomaterials Pty, Ltd.
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
- Polynovo Biomaterials Pty, Ltd.
Sources (1)
- FDA UDI 03db06d9-0081-47be-9118-b0ea077bb76a 37 fields · synced May 30, 2026