Symphony OPX™ Proliferative Bioscaffold

Primary DI
09421908222577
Brand
Symphony OPX™ Proliferative Bioscaffold
Company
AROA BIOSURGERY LIMITED
Model
SY02HA006L
Device description
Symphony OPX is a sterile, single use wound care device manufactured by incorporating layers of extracellular matrix, derived from ovine (sheep) forestomach, with a layer of hyaluronic acid. This advanced wound care device retains the innate biological structure of the native ECM, along with associated macromolecules including elastin, fibronectin, glycosaminoglycans and laminin. The device scaffold enables cell infiltration to aid in tissue repair.
Published
2026-10-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGNWound dressing with animal-derived material(s)

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
09421908222577PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09421908222577094219082225779421908222577

GMDN Terms#

Term, Definition table
TermDefinition
Animal-derived wound matrix dressingA bioabsorbable animal-derived protein matrix [e.g., peptides derived from collagen] designed to provide: 1) a matrix of structural proteins and/or 2) a skin template of living cells [fibroblasts], to facilitate the infiltration/attachment of native cells/tissues (e.g., blood vessels) for wound/skin healing. It is available in various forms [e.g., solution, powder, occlusive/semi-occlusive cover (non-oral)] and may include additional compounds (e.g., alginate, fatty acids). It may be intended to be covered with a secondary dressing. It is commonly intended for treating partial- and full-thickness wounds, ulcers, and draining, surgical, and traumatic wounds. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Area/Surface Area0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature in a dry environment.

Regulatory Flags#

DUNS number
594540572
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
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
09421908222430Myriad Matrix™ Restore Restorative BioscaffoldSR02LG016S2026-01-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09421908222522Symphony™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222553Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222560Symphony 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
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