Home GUDID 00191083027951 MIS FUSION Instruments
Primary DI 00191083027951
Brand MIS FUSION Instruments
Company Rti Surgical, Inc.
Model 724-591
Catalog number 724-591
Device description FUSION MIS 6mm OSTEOTOME
Published 2020-09-25
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name GFI OSTEOTOME, MANUAL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GFI Osteotome, Manual General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00191083027951 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 00191083027951 00191083027951 191083027951 0191083027951
GMDN Terms# Term, Definition table Term Definition Orthopaedic osteotome A chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 117560455 Device count 1 Premarket exempt true Lot or batch true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00191083047676 RapidEase™ 4564SC 4564SC 2023-11-03 00191083047683 RapidEase™ 4561SC 4561SC 2023-11-03 00191083024554 Streamline TL Spinal Fixation System 10-55-PR-100 10-55-PR-100 2021-06-25 00191083024585 Streamline TL Spinal Fixation System 10-55-PR-115 10-55-PR-115 2021-06-25 00191083024608 Streamline TL Spinal Fixation System 10-55-PR-125 10-55-PR-125 2021-06-25 00191083024615 Streamline TL Spinal Fixation System 10-55-PR-130 10-55-PR-130 2021-06-25 00191083024639 Streamline TL Spinal Fixation System 10-55-PR-140 10-55-PR-140 2021-06-25 00191083024653 Streamline TL Spinal Fixation System 10-55-PR-150 10-55-PR-150 2021-06-25 00191083024707 Streamline TL Spinal Fixation System 10-55-PR-55 10-55-PR-55 2021-06-25 00191083024745 Streamline TL Spinal Fixation System 10-55-PR-75 10-55-PR-75 2021-06-25 00191083024769 Streamline TL Spinal Fixation System 10-55-PR-85 10-55-PR-85 2021-06-25 00191083024776 Streamline TL Spinal Fixation System 10-55-PR-90 10-55-PR-90 2021-06-25 00191083024806 Streamline TL Spinal Fixation System 10-55-RH-150 10-55-RH-150 2021-06-25 00191083024844 Streamline TL Spinal Fixation System 10-55-RHC-200 10-55-RHC-200 2021-06-25 00191083024851 Streamline TL Spinal Fixation System 10-55-RHC-400 10-55-RHC-400 2021-06-25 00191083024868 Streamline TL Spinal Fixation System 10-55-RHC-600 10-55-RHC-600 2021-06-25 00191083024875 Streamline TL Spinal Fixation System 10-55-RR-100 10-55-RR-100 2021-06-25 00191083024882 Streamline TL Spinal Fixation System 10-55-RR-110 10-55-RR-110 2021-06-25 00191083024899 Streamline TL Spinal Fixation System 10-55-RR-35 10-55-RR-35 2021-06-25 00191083024905 Streamline TL Spinal Fixation System 10-55-RR-40 10-55-RR-40 2021-06-25
Other Devices Sharing Product Codes# 
rtix.com