DEVICE: Synthacer (04250971400637)

Device Identifier (DI) Information

Synthacer
T62GR03-1
In Commercial Distribution
6.2GR03
medArtis Medizinprodukte und Forschung Aktiengesellschaft
04250971400637
GS1

1
313163545 *Terms of Use
Synthacer® 600 rounded granules Ceround®, HA, particle size 2.6 - 4.8 mm
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
17751 Bone matrix implant, synthetic, non-antimicrobial
A 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 does not include an antimicrobial agent(s). 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.
Active true
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FDA Product Code

[?]
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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Pore Size: 600 Micrometer
Device Size Text, specify: Particle Size 2.6 - 4.8 mm
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Device Record Status

892d5347-a9c3-4e9e-b344-7453400cd30e
June 19, 2020
4
October 24, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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