DEVICE: Synthacer/Syntricer (04250971422059)

Device Identifier (DI) Information

Synthacer/Syntricer
T672CB03-2-1
In Commercial Distribution
6.2/7.2CB03
medArtis Medizinprodukte und Forschung Aktiengesellschaft
04250971422059
GS1

1
313163545 *Terms of Use
Synthacer®/Syntricer® 600 Ceraball®, mixture of HA and TCP, diameter 3 mm, 2 ml
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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
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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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K041177 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
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Total Volume: 2 Milliliter
Pore Size: 600 Micrometer
Outer Diameter: 3 Millimeter
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Device Record Status

98797e16-0621-4e4a-a216-0c94f189f8b3
July 06, 2018
3
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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Yes
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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