FDA.reportPublic FDA data

Fortiva™ Porcine Dermis

Primary DI
04041543311983
Brand
Fortiva™ Porcine Dermis
Company
Tutogen Medical GmbH
Model
PD0606
Catalog number
PD0606
Device description
Fortiva™ porcine dermis is an extracellular collagen matrix comprised of porcine dermal tissue that has been processed and terminally sterilized via gamma irradiation. The surgical mesh device is designed to perform as a scaffold that allows for neovascularization and permits replacement of the device with patient’s tissue. The sterile device is supplied pre-hydrated in water and is provided in various sizes. The device is ready for immediate use without extra preparation (i.e., no rinsing, no s
Published
2015-10-24
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

Product Codes#

Code, Name table
CodeName
FTMMesh, surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTMMesh, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04041543311983PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04041543311983040415433119834041543311983

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
343337499
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04041543305463COPIOS® Pericardium Membranexz0112777762015-12-14
04041543305470COPIOS® Pericardium Membranexz0123777772015-12-14
04041543305487COPIOS® Pericardium Membranexz0134777782015-12-14
04041543311846Tutopatch™ bovine pericardium 6x8 cmBP0608BP06082015-12-14
04041543311853Tutopatch™ bovine pericardium 8x11 cmBP0811BP08112015-12-14
04041543311860Tutopatch™ bovine pericardium 8x14 cmBP0814BP08142015-12-14
04041543311877Tutopatch™ bovine pericardium 8x16 cmBP0816BP08162015-12-14
04041543311884Tutopatch™ bovine pericardium 8x18 cmBP0818BP08182015-12-14
04041543311891Tutopatch™ bovine pericardium10x12.5 cmBP1013BP10132015-12-14
04041543311907Tutopatch™ bovine pericardium 10x16 cmBP1016BP10162015-12-14
04041543311914Tutopatch™ bovine pericardium 12x12 cmBP1212BP12122015-12-14
04041543311921Tutopatch™ bovine pericardium 12x16 cmBP1216BP12162015-12-14
04041543311945Tutopatch™ bovine pericardium 14x20 cmBP1420BP14202015-12-14
04041543311952Tutomesh™ bovine pericardium10x16 cmBP3016BP30162015-12-14
04041543311969Tutomesh™ bovine pericardium 13x22 cmBP3322BP33222015-12-14
04041543311976Tutopatch™ bovine pericardium 6x18 cmBP0618BP06182015-12-14
04041543311990Fortiva™ Porcine DermisPD0808PD08082015-10-24
04041543312003Fortiva™ Porcine DermisPD0822PD08222015-10-24
04041543312010Fortiva™ Porcine DermisPD1010PD10102015-10-24
04041543312027Fortiva™ Porcine DermisPD1016PD10162015-10-24

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