FDA.reportPublic FDA data

Endoform Myriad

Primary DI
09421905067393
Brand
Endoform Myriad
Company
AROA BIOSURGERY LIMITED
Model
MR05LG1020
Catalog number
SR05LG1020US
Device description
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
2019-03-31
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
KGNDressing, Wound, Collagen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTLMesh, Surgical, PolymericGeneral, 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
09421904065697PreviousGS10
09421905067393PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09421904065697094219040656979421904065697
09421905067393094219050673939421905067393

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
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
877-627-6224customerservice@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
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
09421906017281Endoform™ Natural Restorative Bioscaffold5293112021-08-20
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
09421906017502Endoform™ Antimicrobial Restorative Bioscaffold6293112021-08-20
09421906661903OviTex® IHRF10244-1017I2024-03-21
09421906661927OviTex® IHRF10243-1017I2024-03-21
09421906661552OviTex® LPRF10244-1525L2023-06-15
09421906661569OviTex® LPRF10244-1520L2023-06-15
09421906017670Myriad Matrix™ Soft Tissue BioscaffoldSR02LG1010US2022-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09421908222409Myriad Matrix™ Restore Restorative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-01-30
09421908222423Myriad Matrix™ Restore Restorative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-01-30
09421908222447Myriad Matrix™ Restore Restorative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-01-30
10381780545316PriMatrix®INTEGRA LIFESCIENCESKGN2026-01-12
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10381780545347PriMatrix®INTEGRA LIFESCIENCESKGN2026-01-12
10381780545354PriMatrix®INTEGRA LIFESCIENCESKGN2026-01-12
10381780545361PriMatrix®INTEGRA LIFESCIENCESKGN2026-01-12
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10381780545408PriMatrix®INTEGRA LIFESCIENCESKGN2026-01-12
10381780545415PriMatrix®INTEGRA LIFESCIENCESKGN2026-01-12
10381780545576PriMatrix®INTEGRA LIFESCIENCESKGN2026-01-12
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10381780545613PriMatrix®INTEGRA LIFESCIENCESKGN2026-01-12
10381780545620PriMatrix®INTEGRA LIFESCIENCESKGN2026-01-12
10381780545637PriMatrix®INTEGRA LIFESCIENCESKGN2026-01-12
10381780545644PriMatrix®INTEGRA LIFESCIENCESKGN2026-01-12
10381780545651PriMatrix®INTEGRA LIFESCIENCESKGN2026-01-12
09421907331874OviTex® CoreAROA BIOSURGERY LIMITEDFTL2025-11-26
09421907331928OviTex® CoreAROA BIOSURGERY LIMITEDFTL2025-11-26
09421907331966OviTex® 1SAROA BIOSURGERY LIMITEDFTL2025-11-26
09421907331997OviTex® 1SAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222072OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222089OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222119OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTL2025-11-26