DEVICE: COPIOS® Pericardium Membrane (04041543305470)

Device Identifier (DI) Information

COPIOS® Pericardium Membrane
xz0123
In Commercial Distribution
77777
Tutogen Medical GmbH
04041543305470
GS1

1
343337499 *Terms of Use
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
Yes
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GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
58740 Dental/maxillofacial soft-tissue biomatrix implant, animal-derived
A bioabsorbable animal-derived collagen (e.g., porcine) intended to be used to aid in the regeneration of oral soft tissue, lost due to periodontal disease or trauma, through promotion of new blood vessels and/or by providing a temporary scaffold for tissue ingrowth; 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 which may be fixed to soft tissues with sutures; it is applied to soft tissue during periodontal flap surgery and guided tissue regeneration (GTR) surgical procedures. This is a single-use device.
Active true
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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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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K073097 000
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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
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 Record Status

1a610dd6-3d7e-4835-9f55-33fe0c163766
December 18, 2023
7
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
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
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Customer Contact

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No Customer Contact currently defined
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