DEVICE: Synthacer/Syntricer (04250971421786)
Device Identifier (DI) Information
Synthacer/Syntricer
T672G01-5-1
In Commercial Distribution
6.2/7.2G01
medArtis Medizinprodukte und Forschung Aktiengesellschaft
T672G01-5-1
In Commercial Distribution
6.2/7.2G01
medArtis Medizinprodukte und Forschung Aktiengesellschaft
Synthacer®/Synthacer® 600 powder, mixture of HA and TCP, particle size 0.1 - 0.9 mm, 5 ml
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MQV | Filler, Bone Void, Calcium Compound |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K041177 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Pore Size: 600 Micrometer |
Total Volume: 5 Milliliter |
Device Size Text, specify: Particle Size 0.1 - 0.9 mm |
Device Record Status
6d431937-4201-4e73-bcc1-1dffa9f8d1ca
July 06, 2018
3
October 24, 2015
July 06, 2018
3
October 24, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined