FDA.reportPublic FDA data

Endoform™ Natural Restorative Bioscaffold

Primary DI
09421906017298
Brand
Endoform™ Natural Restorative Bioscaffold
Company
AROA BIOSURGERY LIMITED
Model
529304
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

Contact Domains#

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
09421906017403PackageGS110In Commercial Distribution
09421906017298PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09421906017403094219060174039421906017403
09421906017298094219060172989421906017298

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-627-6224customerservice@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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