Home GUDID H98071000098S0 ChronOS
Primary DI H98071000098S0
Brand ChronOS
Company SYNTHES (U.S.A.) LP
Model 710.000.98S
Catalog number 71000098S
Device description CHRONOS(TM) BETA-TCP GRANULES 0.5-0.7MM/0.5CC-STERILE
Published 2015-09-14
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name LPK Bone grafting material, for dental bone repair
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LPK Bone grafting material, for dental bone repair
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10887587060743 Primary GS1 0 H98071000098S0 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10887587060743 10887587060743
GMDN Terms# Term, Definition table Term 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.
Regulatory Flags# DUNS number 832637081 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 04260476431005 IngeniOS ß-TCP Bioactiv Synthetic Bone Particles curasan AG LPK 2019-10-30 04260476431012 IngeniOS ß-TCP Bioactiv Synthetic Bone Particles curasan AG LPK 2019-10-30 04260476431029 IngeniOS ß-TCP Bioactiv Synthetic Bone Particles curasan AG LPK 2019-10-30 04260476431036 IngeniOS ß-TCP Bioactiv Synthetic Bone Particles curasan AG LPK 2019-10-30 04260476431104 IngeniOS ß-TCP Bioactiv Synthetic Bone Particles curasan AG LPK 2019-10-30 04260476431111 IngeniOS ß-TCP Bioactiv Synthetic Bone Particles curasan AG LPK 2019-10-30 04260476431128 IngeniOS ß-TCP Bioactiv Synthetic Bone Particles curasan AG LPK 2019-10-30 42604764310052 IngeniOS ß-TCP Bioactiv Synthetic Bone Particles curasan AG LPK 2017-10-24 42604764310120 IngeniOS ß-TCP Bioactiv Synthetic Bone Particles curasan AG LPK 2017-10-24 42604764310298 IngeniOS ß-TCP Bioactiv Synthetic Bone Particles curasan AG LPK 2017-10-24 42604764310366 IngeniOS ß-TCP Bioactiv Synthetic Bone Particles curasan AG LPK 2017-10-24 42604764311042 IngeniOS ß-TCP Bioactiv Synthetic Bone Particles curasan AG LPK 2017-10-24 42604764311110 IngeniOS ß-TCP Bioactiv Synthetic Bone Particles curasan AG LPK 2017-10-24 42604764311288 IngeniOS ß-TCP Bioactiv Synthetic Bone Particles curasan AG LPK 2017-10-24 H98071000398S0 ChronOS SYNTHES (U.S.A.) LP LPK 2015-09-14
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