FDA.reportPublic FDA data

Myriad Matrix™ Soft Tissue Bioscaffold

Primary DI
09421906017663
Brand
Myriad Matrix™ Soft Tissue Bioscaffold
Company
AROA BIOSURGERY LIMITED
Model
SR02LG0505US
Device description
Myriad Matrix™ is an intact extracelluar matrix (ECM) derived from ovine (sheep) forestomach tissue. This advanced ECM scaffold is non-reconstituted collagen, thus it retains the innate biological structure and function of the native ECM associated macromolecules including elastin, fibronectin, glycosaminoglycans and laminin. Myriad Matrix transforms into a soft conforming sheet, which is incorporated into the surrounding tissue over time. The device is supplied sterile and dry in a variety of sizes and thicknesses, which can be trimmed to size or applied whole to meet the individual patient's needs.
Published
2022-03-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTMMesh, Surgical
KGNDressing, Wound, Collagen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTMMesh, SurgicalGeneral, Plastic Surgery2
KGNWound Dressing With Animal-Derived Material(S)UnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162461000
K171231000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162461000Endoform Plastics and Reconstructive MatrixAroa Biosurgery (Formerly Mesynthes Limited)2016-12-20FTM
K171231000Endoform Topical MatrixAroa Biosurgery2017-06-14KGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09421906017663PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09421906017663094219060176639421906017663

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
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Myriad Matrix should be stored at room temperature in a clean and dry area.
Special Storage Condition, Specify00Store at room temperature in a dry environment.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8776276224customerservice@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
09421904065727OviTex® 1SF10246-2530P2018-12-13
09421904065734OviTex® 1SF10246-2540P2018-12-13
09421904065741OviTex® 2SF10248-2530P2018-12-13
09421904065758OviTex® 2SF10248-2540P2018-12-13
09421904065246OviTex® CoreF10254-1020G2016-09-24
09421906017281Endoform™ Natural Restorative Bioscaffold5293112021-08-20
09421908222515Myriad Meshed Soft Tissue BioscaffoldMS01FV20302026-07-04
09421906017274Endoform™ Natural Restorative Bioscaffold5293122021-08-20
09421906661910OviTex® IHRF10243-1317I2024-03-21
09421906017625Myriad Matrix™ Soft Tissue BioscaffoldSR05LG0505US2021-08-12
09421906017236Endoform™ Natural Restorative Bioscaffold5293162021-08-20
09421906017243Endoform™ Natural Restorative Bioscaffold5293152021-08-20
09421906017250Endoform™ Natural Restorative Bioscaffold5293142021-08-20
09421906017267Endoform™ Natural Restorative Bioscaffold5293132021-08-20
09421906017304Endoform™ Natural Restorative Bioscaffold5293022021-08-20
09421906017434Endoform™ Antimicrobial Restorative Bioscaffold6293042021-08-20
09421906017465Endoform™ Antimicrobial Restorative Bioscaffold6293152021-08-20
09421906017472Endoform™ Antimicrobial Restorative Bioscaffold6293142021-08-20
09421906017489Endoform™ Antimicrobial Restorative Bioscaffold6293132021-08-20
09421906017496Endoform™ Antimicrobial Restorative Bioscaffold6293122021-08-20

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