FDA.reportPublic FDA data

Symphony™ Proliferative Bioscaffold

Primary DI
09421907331522
Brand
Symphony™ Proliferative Bioscaffold
Company
AROA BIOSURGERY LIMITED
Model
CM03HA012R
Catalog number
CM03HA012R
Device description
Symphony™ is a sterile, single use wound dressing manufactured by incorporating a layer of glycosaminoglycans between sheets of ovine forestomach-derived extracellular matrix.
Published
2024-03-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGNDressing, Wound, Collagen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGNWound Dressing With Animal-Derived Material(S)UnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200413000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200413000SymphonyAroa Biosurgery , Ltd.2020-07-29KGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09421907331522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09421907331522094219073315229421907331522

GMDN Terms#

Term, Definition table
TermDefinition
Collagen wound matrix dressingA sterile, bioabsorbable, animal-derived collagen protein matrix designed to provide an occlusive/semi-occlusive cover for wound healing (non-oral) and/or a skin template of living cells (fibroblasts) and/or structural proteins to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration. The device is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, and/or surgical wounds. It may combine collagen with other compounds or supplemental dressing materials (e.g., alginate); it is supplied in various forms. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-627-6224CustomerService@aroabio.com

Regulatory Flags#

DUNS number
594540572
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09421908222522Symphony™ Proliferative BioscaffoldCM03HA003R2026-10-20
09421908222553Symphony OPX™ Proliferative BioscaffoldSY02HA003H2026-10-20
09421908222560Symphony OPX™ Proliferative BioscaffoldSY02HA004H2026-10-20
09421908222577Symphony OPX™ Proliferative BioscaffoldSY02HA006L2026-10-20
09421908222584Symphony OPX™ Proliferative BioscaffoldSY02HA012L2026-10-20
09421908222591Symphony OPX™ Proliferative BioscaffoldSY02HA016L2026-10-20
09421908222607Symphony OPX™ Proliferative BioscaffoldSY02HA025L2026-10-20
09421908222614Symphony OPX™ Proliferative BioscaffoldSY02HA050L2026-10-20
09421908222621Symphony OPX™ Proliferative BioscaffoldSY03HA003H2026-10-20
09421908222638Symphony OPX™ Proliferative BioscaffoldSY03HA004H2026-10-20
09421908222645Symphony OPX™ Proliferative BioscaffoldSY03HA006L2026-10-20
09421908222652Symphony OPX™ Proliferative BioscaffoldSY03HA012L2026-10-20
09421908222669Symphony OPX™ Proliferative BioscaffoldSY03HA016L2026-10-20
09421908222676Symphony OPX™ Proliferative BioscaffoldSY03HA025L2026-10-20
09421908222683Symphony OPX™ Proliferative BioscaffoldSY03HA050L2026-10-20
09421908222690Symphony OPX™ Proliferative BioscaffoldSY02HA002H2026-10-20
09421908222706Symphony OPX™ Proliferative BioscaffoldSY03HA002H2026-10-20
09421908222409Myriad Matrix™ Restore Restorative BioscaffoldSR02LG004S2026-01-30
09421908222416Myriad Matrix™ Restore Restorative BioscaffoldSR02LG006R2026-01-30
09421908222423Myriad Matrix™ Restore Restorative BioscaffoldSR02LG012R2026-01-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860008106599NeoMatriX Wound MatrixNEXTGEN BIOLOGICS INCKGN2026-10-21
09421908222522Symphony™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222553Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222560Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222577Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222584Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222591Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222607Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222614Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222621Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222638Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222645Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222652Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222669Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222676Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222683Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222690Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222706Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
07610221017621DermaFormGeistlich Pharma AGKGN2026-10-19
00810226442979Vive CareVIVE HEALTH LLCKGN2026-10-14
00850083365035LaviorLavior Pharma Inc.KGN2026-10-08
00850083365042LaviorLavior Pharma Inc.KGN2026-10-08
00850083365059LaviorLavior Pharma Inc.KGN2026-10-08
00850065122236VitaleCELLERA LLCKGN2026-10-01
00850088144963CARBOUNingbo kehu Medical Technology Co.,Ltd.KGN2026-09-30
00860013117504DermiSphere™ hDRTFesariustherapeutics Inc.KGN2026-09-24
00860013117511DermiSphere™ hDRTFesariustherapeutics Inc.KGN2026-09-24
00850016008190BaseMEMViscus Biologics LLCKGN2026-09-21
00850016008206BaseMEMViscus Biologics LLCKGN2026-09-21
00850016008220BaseMEMViscus Biologics LLCKGN2026-09-21