DEVICE: Neoss Implant System (05060440330940)

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Device Identifier (DI) Information

Neoss Implant System
64012
64012
Neoss Ltd
05060440330940
GS1
1
Neoss Ti Reinforced Membrane - L I
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
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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
Pliable-polymer dental regeneration membrane, bioabsorbable, tacked A sterile bioabsorbable material intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, by acting as a barrier to prevent the down-growth of soft tissue (connective tissue and epithelial cells) into the underlying bone during the healing period. It is a synthetic polymer material that is held in place with bioabsorbable tacks fixed into the jawbone; it is applied between soft tissue and bone during periodontal flap surgery and other guided bone regeneration (GBR) and guided tissue regeneration (GTR) surgical procedures. The tacks and a plasticizer used to temporarily soften the membrane may be included. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
NPK Barrier, Synthetic, Intraoral
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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
No storage/handling found
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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
May 29, 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
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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