FDA.reportPublic FDA data

Endoform Antimicrobial Dermal Template

Primary DI
09421904065611
Brand
Endoform Antimicrobial Dermal Template
Company
AROA BIOSURGERY LIMITED
Model
629311
Catalog number
629311
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
OTC
false
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
09421904065529PackageGS110In Commercial Distribution
09421904065611PackageGS1100In Commercial Distribution
09421904065451PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09421904065529094219040655299421904065529
09421904065611094219040656119421904065611
09421904065451094219040654519421904065451

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
Length5Centimeter
Width5Centimeter

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

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
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
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
09421906017281Endoform™ Natural Restorative Bioscaffold5293112021-08-20
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
09421906017502Endoform™ Antimicrobial Restorative Bioscaffold6293112021-08-20
09421906661903OviTex® IHRF10244-1017I2024-03-21
09421906661927OviTex® IHRF10243-1017I2024-03-21
09421906661552OviTex® LPRF10244-1525L2023-06-15
09421906661569OviTex® LPRF10244-1520L2023-06-15

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