Myriad Ultra™ Reinforced BioScaffold – Permanent (PP)

Primary DI
09421906661897
Brand
Myriad Ultra™ Reinforced BioScaffold – Permanent (PP)
Company
AROA BIOSURGERY LIMITED
Model
LP04PP1525
Catalog number
LP04PP1525
Device description
Myriad Ultra ™ Reinforced Tissue Matrix is a sterile bioscaffold composed of ovine (sheep) derived extracellular matrix (ECM) and monofilament polypropylene colored with ([phathalocyaninato(2-)] copper).Myriad™ is intended for applications in plastic and reconstructive surgery or to cover, protect and provide a moist wound environment. The device may be fixed, via sutures, staples or tacks to surround the tissue if desired.
Published
2022-11-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTLMesh, Surgical, Polymeric
FTMMesh, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTLMesh, Surgical, PolymericGeneral, Plastic Surgery2
FTMMesh, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153632000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153632000Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)2016-06-16FTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09421906661897PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09421906661897094219066618979421906661897

GMDN Terms#

Term, Definition table
TermDefinition
Extra-gynaecological surgical mesh, biologic-polymer compositeA partially-bioabsorbable, implantable material (e.g., flat sheet) made from both a bioabsorbable animal-derived biologic (e.g., porcine collagen) and a non-bioabsorbable synthetic polymer (e.g., polypropylene) intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. It may also be intended as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be supplied with the mesh.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length20Centimeter
Width15Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+6498693035Minh.Lam@aroabio.com

Regulatory Flags#

DUNS number
594540572
Device count
1
Lot or batch
true
Expiration date on label
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

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