Home GUDID 00845694011440 OsteoMed
Primary DI 00845694011440
Brand OsteoMed
Company OSTEOMED LLC
Model 371-0227
Catalog number 371-0227
Device description Metatarsal Stem Trial, Large
Published 2016-07-21
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name LZJ PROSTHESIS, TOE (METATARSOPHALANGEAL), JOINT, METAL/POLYMER, SEMI-CONSTRAINED
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LZJ Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained Unknown U
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00845694011440 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 00845694011440 00845694011440 845694011440 0845694011440
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.
Device Sizes# Type, Value, Unit table Type Value Unit Length 30 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 0 275 Degrees Fahrenheit
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 606417780 Device count 1 DM exempt true Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00885556828229 Movement Great Toe System Smith & Nephew, Inc. LZJ 2022-12-22 00885556828250 Movement Great Toe System Smith & Nephew, Inc. LZJ 2022-12-22 00885556828281 Movement Great Toe System Smith & Nephew, Inc. LZJ 2022-12-22 00885556828311 Movement Great Toe System Smith & Nephew, Inc. LZJ 2022-12-22 00885556828410 Movement Great Toe System Smith & Nephew, Inc. LZJ 2022-12-21 00885556828441 Movement Great Toe System Smith & Nephew, Inc. LZJ 2022-12-21 00885556828472 Movement Great Toe System Smith & Nephew, Inc. LZJ 2022-12-21 00885556828502 Movement Great Toe System Smith & Nephew, Inc. LZJ 2022-12-21 00880304216860 TOTAL TOE SYSTEM Biomet Orthopedics, LLC LZJ 2018-12-19 00880304216907 TOTAL TOE SYSTEM Biomet Orthopedics, LLC LZJ 2018-12-19 00880304216914 TOTAL TOE SYSTEM Biomet Orthopedics, LLC LZJ 2018-12-19 00880304217003 TOTAL TOE SYSTEM Biomet Orthopedics, LLC LZJ 2018-12-19 M2480120031 KGTI™ Kinetik Great Toe Implant System Ascension Orthopedics, Inc. LZJ 2017-10-09 M2480120101 KGTI™ Kinetik Great Toe Implant System Ascension Orthopedics, Inc. LZJ 2017-10-09 M2480120021 KGTI™ Kinetik Great Toe Implant System INTEGRA LIFESCIENCES CORPORATION LZJ 2017-10-09 M2480120041 KGTI™ Kinetik Great Toe Implant System INTEGRA LIFESCIENCES CORPORATION LZJ 2017-10-09 M2480120051 KGTI™ Kinetik Great Toe Implant System INTEGRA LIFESCIENCES CORPORATION LZJ 2017-10-09 M2480120061 KGTI™ Kinetik Great Toe Implant System INTEGRA LIFESCIENCES CORPORATION LZJ 2017-10-09 M2480120071 KGTI™ Kinetik Great Toe Implant System INTEGRA LIFESCIENCES CORPORATION LZJ 2017-10-09 M2480120121 KGTI™ Kinetik Great Toe Implant System INTEGRA LIFESCIENCES CORPORATION LZJ 2017-10-09 M2480120141 KGTI™ Kinetik Great Toe Implant System INTEGRA LIFESCIENCES CORPORATION LZJ 2017-10-09 M2480120161 KGTI™ Kinetik Great Toe Implant System INTEGRA LIFESCIENCES CORPORATION LZJ 2017-10-09 00845694014632 OsteoMed OSTEOMED LLC LZJ 2016-10-14 00845694028516 OsteoMed OSTEOMED LLC LZJ 2016-10-14 00845694028523 OsteoMed OSTEOMED LLC LZJ 2016-10-14 00845694036894 OsteoMed OSTEOMED LLC LZJ 2016-10-14 00845694036900 OsteoMed OSTEOMED LLC LZJ 2016-10-14 00845694036917 OsteoMed OSTEOMED LLC LZJ 2016-10-14 00845694036931 OsteoMed OSTEOMED LLC LZJ 2016-10-14 00845694036962 OsteoMed OSTEOMED LLC LZJ 2016-10-14
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