DEVICE: CERAMENT™BONE VOID FILLER (07350055430042)

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Device Identifier (DI) Information

CERAMENT™BONE VOID FILLER
A0210-09
A0210-09
Bone Support AB
07350055430042
GS1
1
CERAMENT™|BONE VOID FILLER is an injectable and moldable ceramic bone substitute intended for bone voids. The material consists of a powder and a liquid component. The major constituents of the powder are hydroxyapatite and calcium sulfate hemihydrate. The liquid component contains iohexol (C-TRU) as a radio-opacification enhancer. Mixing the components, with the combined mixing injection device (CMI), results in a viscous material intended to set ex-vivo or in-vivo. By combining hydroxyapatite and calcium sulfate an optimal balance is achieved between implant resorption rate and bone in-growth rate. Calcium sulfate acts as a resorbable carrier for hydroxyapatite. Hydroxyapatite has a slow resorption rate, high osteoconductivity, promoting bone in-growth, and gives long term structural support to the newly formed bone. The ceramic bone substitute material is placed into the bone void under visual inspection or under radiographic monitoring during open or percutaneous surgery, with the use of the accompanying injection device (ID).
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
Yes
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
Bone matrix implant, synthetic A sterile bioabsorbable device made of synthetic material intended to be implanted into the body to provide osteoconductive bone-tissue scaffolds, and sometimes osteovascularization, to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis). It may be made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), bioactive glasses/minerals/metals (e.g., strontium), or bioabsorbable polymers. It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts and is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable/fluid materials.
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FDA Product Code

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Product Code Product Code Name
MQV Filler, Bone Void, Calcium Compound
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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
Total Volume: 5 Milliliter
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Device Status

In Commercial Distribution
September 17, 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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574.267.6639
product.complaints@biomet.com
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