Home GUDID B447RM4405110 Mixing and Delivery System
Primary DI B447RM4405110
Brand Mixing and Delivery System
Company BONE SOLUTIONS, INC.
Model Mechanical Advantage Pak
Catalog number RM 44-051
Device description The Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.
Published 2020-07-30
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 FMF Syringe, Piston
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FMF Syringe, Piston General Hospital 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B447RM4405110 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Bone graft delivery kit A collection of sterile devices intended to be used to prepare and/or deliver bone graft material during an orthopaedic surgical procedure. It typically includes aspirating/delivery/mixing syringe(s), an adaptor, and a needle/cannula. It allows for the aspiration and/or premixing of bone marrow, autologous blood, plasma, intravenous fluids (IVF), and bone void filler (e.g., allograft, autograft, synthetic bone graft material), and their delivery to the surgical site. This is a single-use device.
Regulatory Flags# DUNS number 003506272 Device count 1 DM exempt true Premarket exempt true Kit true Lot or batch true Serial number true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850080243145 T-Han Delivery System 4.2 x 180mm RM44-053 2026-02-13 00850080243152 T-Han Delivery System 4.2 x 350mm RM44-063 2026-02-13 00850080243169 T-Han Delivery System 4.2 x 450mm RM44-073 2026-02-13 B4474410000INJ0 Mg OSTEOINJECT® bone graft substitute 10cc 44-100-00-INJ 2024-05-20 B4474405000REV0 Mg OSTEOREVIVE™ bone graft substitute 5cc 44-050-00-REV 2022-02-02 B4474410000REV0 Mg OSTEOREVIVE™ bone graft substitute 10cc 44-100-00-REV 2022-02-02 B4474415000REV0 Mg OSTEOREVIVE™ bone graft substitute 15cc 44-150-00-REV 2022-02-02 B4474405000INJ0 Mg OSTEOINJECT® bone graft substitute 5cc 44-050-00-INJ 2022-01-11 B4477120010 Mixing and Delivery System Beat Mat Pak 712001 2021-09-27 B447RM4405010 Mixing and Delivery System Beat Mat Pak RM44-050 2020-07-30 B4474405000STR0 Mg OSTEOCRETE™ bone graft substitute 5cc 44-050-00-STR 2020-02-19 B4474410000BSI0 Mg OSTEOCRETE™ bone graft substitute 10cc 44-100-00-BSI 2020-02-19 B4474410000STR0 Mg OSTEOCRETE™ bone graft substitute 10cc 44-100-00-STR 2020-02-19 B4474415000BSI0 Mg OSTEOCRETE™ bone graft substitute 15cc 44-150-00-BSI 2020-02-19 B4474415000STR0 Mg OSTEOCRETE™ bone graft substitute 15cc 44-150-00-STR 2020-02-19 B4474405000BSI0 Mg OSTEOCRETE™ bone graft substitute 5cc 44-050-00-BSI 2017-08-04 B4477120000 Opus Mg Set - Mixing and Delivery System AUX 712000 2021-09-27 B4477120050 Opus Mg Set BVF 5cc 712005 2021-09-27 B4477120100 Opus Mg Set BVF 10cc 712010 2021-09-27 B4477120150 Opus Mg Set BVF 15cc 712015 2021-09-27
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