FDA.reportPublic FDA data

Endoform™ Natural Restorative Bioscaffold

Primary DI
09421906017359
Brand
Endoform™ Natural Restorative Bioscaffold
Company
AROA BIOSURGERY LIMITED
Model
529315
Catalog number
529315
Device description
Endoform™ Natural Restorative Bioscaffold is a sterile, single use ovine forestomach-derived extracellular matrix intended to cover, protect, and provide a moist wound environment.
Published
2021-08-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
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
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, 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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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