NovoSorb BTM

FDA UDI

Class U (US FDA UDI)

by Polynovo Biomaterials Pty, Ltd.

Identity

Trade Name: NovoSorb BTM FDA UDI
Generic Name: Synthetic wound matrix dressing FDA UDI
Device Name: NovoSorb® BTM is a biodegradable polyurethane porous matrix adhered to a transparent sealing membrane. The sealing membrane is designed to physiologically close the wound limiting evaporative moisture loss during integration of the matrix. NovoSorb® BTM is supplied in various sizes, ranging from 4cm2 to 800cm2. NovoSorb® BTM is a fenestrated single use, terminally sterilized device, individually packed in a transparent polymer pouch enclosed in an aluminized pouch contained in a cardboard envelope. FDA UDI
Model / Reference: BTM-1010 FDA UDI
Description: NovoSorb® BTM is a biodegradable polyurethane porous matrix adhered to a transparent sealing membrane. The sealing membrane is designed to physiologically close the wound limiting evaporative moisture loss during integration of the matrix. NovoSorb® BTM is supplied in various sizes, ranging from 4cm2 to 800cm2. NovoSorb® BTM is a fenestrated single use, terminally sterilized device, individually packed in a transparent polymer pouch enclosed in an aluminized pouch contained in a cardboard envelope. FDA UDI

Identifiers

Primary DI / UDI-DI: 09349155000109 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 10 Centimeter FDA UDI
Width — 10 Centimeter FDA UDI

Category: Synthetic wound matrix dressing

NovoSorb BTM 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:

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 6d55b984-f4c4-44cf-bd19-d192b548b1da 37 fields · synced May 30, 2026