FDA.reportPublic FDA data

Myriad Meshed Expandable Bioscaffold

Primary DI
09421908222164
Brand
Myriad Meshed Expandable Bioscaffold
Company
AROA BIOSURGERY LIMITED
Model
MS01FV1822
Device description
Myriad Meshed™ Expandable Bioscaffold is a sterile, single use ovine forestomach-derived extracellular matrix intended to cover, protect, and provide a moist wound environment.
Published
2024-11-26
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

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
K092096000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092096000ENDOFORM DERMAL TEMPLATEMesynthes, Ltd.2010-01-21KGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09421908222164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09421908222164094219082221649421908222164

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature in a clean and dry area

Sterilization Methods#

Method table
Method

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
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
09421908222447Myriad Matrix™ Restore Restorative BioscaffoldSR02LG025S2026-01-30
09421908222454Myriad Matrix™ Restore Restorative BioscaffoldSR02LG032R2026-01-30
09421908222393Myriad Matrix™ Restore Restorative BioscaffoldSR02LG002D2026-01-30
09421906017496Endoform™ Antimicrobial Restorative Bioscaffold6293122021-08-20
09421905067072Symphony™ Proliferative BioscaffoldCM04HA10102020-12-15
09421905067096Symphony™ Proliferative BioscaffoldCM04HA02022020-12-15
09421905067102Symphony™ Proliferative BioscaffoldCM04HA05052020-12-15
09421904065703OviTex® CoreF10244-2530P2018-12-13
09421904065710OviTex® CoreF10244-2540P2018-12-13
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07610221017621DermaFormGeistlich Pharma AGKGN2026-10-19
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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
05694310969468MariGen® CompactKERECIS hf.KGN2026-09-18
05694310969482MariGen® CompactKERECIS hf.KGN2026-09-18
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05694310969529MariGen® CompactKERECIS hf.KGN2026-09-18
05694310969543SurgiClose® CompactKERECIS hf.KGN2026-09-18
05694310969567SurgiClose® CompactKERECIS hf.KGN2026-09-18
05694310969581SurgiClose® CompactKERECIS hf.KGN2026-09-18
05694310969604SurgiClose® CompactKERECIS hf.KGN2026-09-18
00841277111262Novera RenewHarps USA, Inc.KGN2026-08-26
00850086458062MaxioCel Chitosan Wound DressingAdvamedica Inc.KGN2026-08-21
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