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Symphony™ Proliferative Bioscaffold

FDA UDI

Class U (US FDA UDI)

by Aroa Biosurgery

Identity

Trade Name
Symphony™ Proliferative Bioscaffold FDA UDI
Generic Name
Animal-derived wound matrix dressing FDA UDI
Device Name
Symphony™ is a sterile, single use wound dressing manufactured by incorporating a layer of glycosaminoglycans between sheets of ovine forestomach-derived extracellular matrix. FDA UDI
Model / Reference
CM03HA100S FDA UDI
Description
Symphony™ is a sterile, single use wound dressing manufactured by incorporating a layer of glycosaminoglycans between sheets of ovine forestomach-derived extracellular matrix. FDA UDI

Identifiers

Catalog Number
CM03HA100S FDA UDI
Primary DI / UDI-DI
09421907331584 FDA UDI
510(k) Number
K200413 FDA UDI
FDA Product Code
KGN FDA UDI
GMDN Term
Animal-derived wound matrix dressing FDA UDI

Classification

Device Class
U FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI

Symphony™ Proliferative Bioscaffold by Aroa Biosurgery — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K200413 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Aroa Biosurgery

Sources (1)

  • FDA UDI 1340055e-0d63-4eb2-af3c-755eab23d9e8 38 fields · synced May 31, 2026