Home GUDID 00191083028149 MIS FUSION Instruments
Primary DI 00191083028149
Brand MIS FUSION Instruments
Company Xtant Medical Holdings, Inc.
Model 724-868
Catalog number 724-868
Device description SHARP TOOTH BAYONETTE CURETTE, 45 SIDE
Published 2020-10-08
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 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 00191083028149 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 00191083028149 00191083028149 191083028149 0191083028149
GMDN Terms# Term, Definition table Term Definition General internal orthopaedic fixation system implantation kit A collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 081224143 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 00849777014144 Vesuvius Flowable DBM, 1cc 4104-K5010DP 2026-09-14 00849777014151 Vesuvius Flowable DBM, 2.5cc 4104-K5025DP 2026-09-14 00849777014168 Vesuvius Flowable DBM, 5cc 4104-K5050DP 2026-09-14 00849777014175 Vesuvius Flowable DBM, 10cc 4104-K5100DP 2026-09-14 00849777014182 Vesuvius Flowable DBM, 0.5cc 4104-K5005DP 2026-09-14 00849777014052 Union DBM, 1cc 11-0001-001 2026-06-24 00849777014069 Union DBM, 2.5cc 11-0001-002 2026-06-24 00849777014076 Union DBM, 5cc 11-0001-005 2026-06-24 00849777014083 Union DBM, 10cc 11-0001-010 2026-06-24 00849777012232 DBM Putty Plus 2.5cc - Jar MM3425 2023-01-11 00849777012256 DBM Putty Plus 10.0cc - Jar MM3500 2023-01-11 00849777013475 OsteoPore Plus DBM Putty 2.5cc Syringe SC-5202-DBM 2025-02-19 00849777013482 OsteoPore Plus DBM Putty 5.0cc Syringe SC-5205-DBM 2025-02-19 00849777013499 OsteoPore Plus DBM Putty 10.0cc Syringe SC-5210-DBM 2025-02-19 00849777013444 OsteoPore Plus DBM Putty 2.5cc Syringe 359425-SC 2025-01-31 00849777013451 OsteoPore Plus DBM Putty 5.0cc Syringe 359450-SC 2025-01-31 00849777013468 OsteoPore Plus DBM Putty 10.0cc Syringe 359500-SC 2025-01-31 00849777012911 Hero DBM Putty, 1.0cc 01001-001 2024-09-17 00849777012928 Hero DBM Putty, 2.5cc 01001-002 2024-09-17 00849777012935 Hero DBM Putty, 5.0cc 01001-005 2024-09-17
Other Devices Sharing Product Codes# 
rtix.com