FDA.reportPublic FDA data

Endoform Antimicrobial Dermal Template

Primary DI
09421904065437
Brand
Endoform Antimicrobial Dermal Template
Company
AROA BIOSURGERY LIMITED
Model
629313
Catalog number
629313
Device description
Endoform Antimicrobial Dermal Template is a sterile, single use ovine forestomach-derived extracellular matrix intended to cover, protect, and provide a moist wound environment.
Published
2018-03-31
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172318000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172318000Endoform Silver Dermal TemplateAroa Biosurgery2017-11-17FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09421904065512PackageGS110In Commercial Distribution
09421904065598PackageGS150In Commercial Distribution
09421904065437PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09421904065512094219040655129421904065512
09421904065598094219040655989421904065598
09421904065437094219040654379421904065437

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
Length12.7Centimeter
Width10Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00clean and dry area, away from direct light
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
Combination product
true
Lot or batch
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

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