DEVICE: COPIOS® Pericardium Membrane (04041543305470)

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Device Identifier (DI) Information

COPIOS® Pericardium Membrane
xz0123
77777
Tutogen Medical GmbH
04041543305470
GS1
1
COPIOS® Pericardium Membrane is a natural collagenous membrane for use in periodontal and/or dental surgical procedures.
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
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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
Dental soft-tissue matrix implant, animal-derived A sterile bioabsorbable material intended to be used to aid in the regeneration of oral soft tissue, lost due to periodontal disease or trauma, primarily through promotion of new blood vessels; it is indicated for various oral soft tissue augmentation procedures (e.g. alveolar ridge reconstruction, localized gingival augmentation, covering of recession defects and extraction sockets). It is a pliable material made of animal-derived collagen (e.g., porcine) which may be fixed to soft tissues with sutures; it is applied to soft tissue by properly prepared flaps during periodontal flap surgery and guided tissue regeneration (GTR) surgical procedures. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
NPL Barrier, animal source, intraoral
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Sterilization

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

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Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
December 14, 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
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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
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None
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Production Identifier(s) in UDI

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Yes
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Customer Contact

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No Customer Contact currently defined
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