Home GUDID 18257200121083 O-GENESIS
Primary DI 18257200121083
Brand O-GENESIS
Company Orthofix US LLC
Model 35-6001SP
Device description CANNULA AND CAPS
Published 2026-07-17
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 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 18257200121083 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 18257200121083 18257200121083
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 927083808 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 09347144013062 Metier Medical METIER MEDICAL LTD FMF 2026-10-19 09347144013123 Metier Medical METIER MEDICAL LTD FMF 2026-10-19 09347144015004 Metier Medical METIER MEDICAL LTD FMF 2026-10-12 09347144016186 Metier Medical METIER MEDICAL LTD FMF 2026-10-12 09347144016216 Metier Medical METIER MEDICAL LTD FMF 2026-10-12 20612479288496 McKesson MCKESSON MEDICAL-SURGICAL INC. FMF 2026-10-08 20612479288526 McKesson MCKESSON MEDICAL-SURGICAL INC. FMF 2026-10-08 10304040193843 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040193850 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040193867 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040193874 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040193881 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040193898 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194109 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194116 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194208 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194215 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194222 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194239 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194246 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194253 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194260 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194277 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194284 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194291 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194307 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194314 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 05391530753982 polycarbonate syringes DMC MEDICAL LIMITED FMF 2026-10-01 05391530753999 polycarbonate syringes DMC MEDICAL LIMITED FMF 2026-10-01 05391530754408 polycarbonate syringes DMC MEDICAL LIMITED FMF 2026-10-01
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