DEVICE: Fortiva™ Porcine Dermis (04041543312010)

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Device Identifier (DI) Information

Fortiva™ Porcine Dermis
PD1010
PD1010
Tutogen Medical GmbH
04041543312010
GS1
1
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
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Multi-purpose surgical mesh, collagen, bioabsorbable A sterile, bioabsorbable, flat or three-dimensional (3-D) implantable material made from animal-derived collagen intended for multiple tissue defect repair/hernia reduction (e.g., inguinal, ventral/incisional, umbilical, femoral) applications including an extra-abdominal application(s) [e.g., plastic surgery, breast reconstruction]. It may also be used as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.
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FDA Product Code

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Product Code Product Code Name
FTM Mesh, surgical
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Keep away from sunlight
Storage Environment Temperature: between 10 and 30 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: 10x10cm
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Device Status

In Commercial Distribution
October 24, 2015

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
Yes
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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