Home GUDID 00850080243176 OSTEOROD Delivery System
Primary DI 00850080243176
Brand OSTEOROD Delivery System
Company BONE SOLUTIONS, INC.
Model OSTEOROD
Catalog number RM44-070
Device description The 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 2026-10-12
Public version status New
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 LXH Orthopedic Manual Surgical Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LXH Orthopedic Manual Surgical Instrument Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850080243176 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 00850080243176 00850080243176 850080243176 0850080243176
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 false Premarket exempt false HCT/P false Kit true 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# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850080243022 Mg OSTEOCRETE™ bone graft substitute 5cc 44-050-00-STR 2026-06-18 00850080243039 Mg OSTEOCRETE™ bone graft substitute 10cc 44-100-00-STR 2026-06-18 00850080243046 Mg OSTEOCRETE™ bone graft substitute 15cc 44-150-00-STR 2026-06-18 00850080243053 Mg OSTEOCRETE™ bone graft substitute 5cc 44-050-00-BSI 2026-06-18 00850080243060 Mg OSTEOCRETE™ bone graft substitute 10cc 44-100-00-BSI 2026-06-18 00850080243077 Mg OSTEOCRETE™ bone graft substitute 15cc 44-150-00-BSI 2026-06-18 00850080243084 Mg OSTEOREVIVE™ bone graft substitute 5cc 44-050-00-REV 2026-06-18 00850080243091 Mg OSTEOREVIVE™ bone graft substitute 10cc 44-100-00-REV 2026-06-18 00850080243107 Mg OSTEOREVIVE™ bone graft substitute 15cc 44-150-00-REV 2026-06-18 00850080243114 Mg OSTEOINJECT® bone graft substitute 5cc 44-050-00-INJ 2026-06-18 00850080243121 Mg OSTEOINJECT® bone graft substitute 10cc 44-100-00-INJ 2026-06-18 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 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 B4477121050 Opus Mg Set BVF 5cc 712105 2021-09-27
Other Devices Sharing Product Codes# 
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