DEVICE: Syntricer (04250971405953)
Device Identifier (DI) Information
Syntricer
T73G01-5-1
In Commercial Distribution
7.3G01
medArtis Medizinprodukte und Forschung Aktiengesellschaft
T73G01-5-1
In Commercial Distribution
7.3G01
medArtis Medizinprodukte und Forschung Aktiengesellschaft
Syntricer® 1000 powder, 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© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. 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.
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Active | true |
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: 1000 Micrometer |
Total Volume: 5 Milliliter |
Device Size Text, specify: Particle Size 0.1 - 0.9 mm |
Device Record Status
7f3972c6-299d-4801-a90a-7d0cb6ade4a0
June 19, 2020
4
October 24, 2015
June 19, 2020
4
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