Fortiva™ Porcine Dermis PD3535

GUDID 04041543312096

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

Tutogen Medical GmbH

Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Primary Device ID04041543312096
NIH Device Record Key301f8832-e08f-4d20-85df-053cc39a9c71
Commercial Distribution StatusIn Commercial Distribution
Brand NameFortiva™ Porcine Dermis
Version Model NumberPD3535
Catalog NumberPD3535
Company DUNS343337499
Company NameTutogen Medical GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

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Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
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Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
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Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
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Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
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Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
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Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
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Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
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Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
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Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
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Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
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Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
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Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
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Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
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Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
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Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
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Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
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Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
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Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
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Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
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Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
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Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
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Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
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Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
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Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
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Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
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Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS104041543312096 [Primary]

FDA Product Code

FTMMesh, surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2022-06-10
Device Publish Date2015-10-24

On-Brand Devices [Fortiva™ Porcine Dermis]

04041543312096Fortiva™ porcine dermis is an extracellular collagen matrix comprised of porcine dermal tissue
04041543312089Fortiva™ porcine dermis is an extracellular collagen matrix comprised of porcine dermal tissue
04041543312072Fortiva™ porcine dermis is an extracellular collagen matrix comprised of porcine dermal tissue
04041543312065Fortiva™ porcine dermis is an extracellular collagen matrix comprised of porcine dermal tissue
04041543312058Fortiva™ porcine dermis is an extracellular collagen matrix comprised of porcine dermal tissue
04041543312041Fortiva™ porcine dermis is an extracellular collagen matrix comprised of porcine dermal tissue
04041543312034Fortiva™ porcine dermis is an extracellular collagen matrix comprised of porcine dermal tissue
04041543312027Fortiva™ porcine dermis is an extracellular collagen matrix comprised of porcine dermal tissue
04041543312010Fortiva™ porcine dermis is an extracellular collagen matrix comprised of porcine dermal tissue
04041543312003Fortiva™ porcine dermis is an extracellular collagen matrix comprised of porcine dermal tissue
04041543311990Fortiva™ porcine dermis is an extracellular collagen matrix comprised of porcine dermal tissue
04041543311983Fortiva™ porcine dermis is an extracellular collagen matrix comprised of porcine dermal tissue

Trademark Results [Fortiva]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FORTIVA
FORTIVA
98395594 not registered Live/Pending
PMI Nutrition International, LLC
2024-02-07
FORTIVA
FORTIVA
87283580 5250540 Live/Registered
Amerix Nutra-Pharmaceutical Inc.
2016-12-29
FORTIVA
FORTIVA
87163619 5189925 Live/Registered
CC SERVE CORPORATION
2016-09-07
FORTIVA
FORTIVA
85637734 not registered Dead/Abandoned
The Dannon Company, Inc.
2012-05-29
FORTIVA
FORTIVA
85129231 4176279 Live/Registered
CC SERVE CORPORATION
2010-09-14
FORTIVA
FORTIVA
79258565 5859632 Live/Registered
Novozymes A/S
2019-03-11
FORTIVA
FORTIVA
79162658 4985790 Live/Registered
TUTOGEN MEDICAL GmbH
2014-12-23
FORTIVA
FORTIVA
78742877 not registered Dead/Abandoned
CompuCredit Intellectual Property Holdings Corp. II
2005-10-28
FORTIVA
FORTIVA
76361434 not registered Dead/Abandoned
Endo Pharmaceuticals Inc.
2002-01-22
FORTIVA
FORTIVA
75386878 not registered Dead/Abandoned
Algos Pharmaceutical Corporation
1997-11-07
FORTIVA
FORTIVA
74553596 not registered Dead/Abandoned
Leading Edge Products, Inc.
1994-07-22
FORTIVA
FORTIVA
74388739 not registered Dead/Abandoned
Glaxo Group Limited
1993-05-05

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