FDA.reportPublic FDA data

Endoform™ Natural Restorative Bioscaffold

Primary DI
09421906017243
Brand
Endoform™ Natural Restorative Bioscaffold
Company
AROA BIOSURGERY LIMITED
Model
529315
Device description
Endoform™ Natural is a 100% w/w intact extracellular matrix (ECM), manufactured from ovine (sheep) forestomach tissue. This advanced wound care device retains the innate biological structure of the native ECM, along with associated macromolecules including elastin, fibronectin, glycosaminoglycans and laminin. When rehydrated with wound exudate or sterile saline, Endoform Natural transforms into a soft conforming sheet, which is incorporated into the wound over time.
Published
2021-08-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGNDressing, Wound, Collagen

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
09421906017359PackageGS110In Commercial Distribution
09421906017243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09421906017359094219060173599421906017359
09421906017243094219060172439421906017243

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
Special Storage Condition, Specify00Endoform Natural should be stored at room temperature in a clean and dry area.

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

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Primary DI, Brand, Company table
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