Home GUDID 00852108006367 Callisto Granules Beta-TCP Synthetic Bone Graft
Primary DI 00852108006367
Brand Callisto Granules Beta-TCP Synthetic Bone Graft
Company CYTOPHIL, INC.
Model 02-050-02-VEX
Catalog number VX-12005
Device description Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intended to fill bony void or gaps of the extremities, posterolateral spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.
Published 2019-10-30
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name MQV Filler, Bone Void, Calcium Compound
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MQV Filler, Bone Void, Calcium Compound Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00852108006367 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00852108006367 00852108006367 852108006367 0852108006367
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.
Device Sizes# Type, Value, Unit table Type Value Unit Total Volume 5 Milliliter
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 15 Degrees Celsius 32 Degrees Celsius
Regulatory Flags# DUNS number 024222105 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00852108006510 Regento Regenerative Scaffold 02-100-03-VTX 202937-10 2019-10-30 00852108006251 Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules 04-030-01-MIL 04-030-01-MIL 2019-10-30 00852108006329 Bank-It Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules 04-030-01-PIB 04-030-01-PIB 2019-10-30 00852108006312 Bank-It Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules 04-010-01-PIB 04-010-01-PIB 2019-10-30 00852108006305 Bank-It Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules 04-005-01-PIB 04-005-01-PIB 2019-10-30 00852108006404 Callisto Granules Beta-TCP Synthetic Bone Graft 02-050-03-VEX VX-23305 2019-10-30 00856509002584 Trab-X SB Synthetic Bone Matrix 02-050-02-VTX 102937-05 2019-10-30 00852108006381 Callisto Granules Beta-TCP Synthetic Bone Graft 02-200-02-VEX VX-12020 2019-10-30 00852108006411 Callisto Granules Beta-TCP Synthetic Bone Graft 02-100-03-VEX VX-23310 2019-10-30 00856509002621 Trab-X SB Synthetic Bone Matrix 02-050-03-VTX 202937-05 2019-10-30 00856509002638 Trab-X SB Synthetic Bone Matrix 02-100-03-VTX 202937-10 2019-10-30 00856509002690 RegenOsteo Orthopedic Beta-TCP 02-050-02-RGO 02-050-02-RGO 2019-10-30 00856509002706 RegenOsteo Orthopedic Beta-TCP 02-100-02-RGO 02-100-02-RGO 2019-10-30 00856509002942 Zavation ZV Graft Beta-TCP Synthetic Bone Graft 02-030-02-ZVG 02-030-02-ZVG 2019-10-30 00856509002959 Zavation ZV Graft Beta-TCP Synthetic Bone Graft 02-030-03-ZVG 02-030-03-ZVG 2019-10-30 00852108006244 Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules 04-010-01-MIL 04-010-01-MIL 2019-10-30 00852108006275 Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules 04-010-02-MIL 04-010-02-MIL 2019-10-30 00852108006282 Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules 04-030-02-MIL 04-030-02-MIL 2019-10-30 00852108006138 Implant Logistics Synthetic Biphasic Dental Bone Graft Granules 03-005-02-MIL 03-005-02-MIL 2019-10-30 00852108006107 Implant Logistics Synthetic Biphasic Dental Bone Graft Granules 03-005-01-MIL 03-005-01-MIL 2019-10-30
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