Home GUDID B8035706130 ORTHOMED
Primary DI B8035706130
Brand ORTHOMED
Company ORTHO-MED, INC.
Model OM 57-0613
Device description FREER ELEVATOR LARGE 6.5MM
Published 2023-12-21
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name HTE Elevator
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HTE Elevator General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B8035706130 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Bone lever/elevator, reusable A manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 086618626 Device count 1 Premarket exempt true 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 09348811078988 INKA The Trustee for KAISER FAMILY TRUST HTE 2026-03-18 10840199507723 Separator KOROS U.S.A., INC. HTE 2024-12-31 10840199507730 Separator KOROS U.S.A., INC. HTE 2024-12-31 10840199507747 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199507754 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199507761 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199507778 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199507785 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199507792 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199507808 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199507815 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199507877 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199507969 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199511447 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199511454 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199526540 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199526557 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199545558 Elevator KOROS U.S.A., INC. HTE 2024-02-05 10840199527288 Elevator KOROS U.S.A., INC. HTE 2024-01-31 10840199527295 Elevator KOROS U.S.A., INC. HTE 2024-01-31 10840199527301 Elevator KOROS U.S.A., INC. HTE 2024-01-31 10840199527318 Elevator KOROS U.S.A., INC. HTE 2024-01-31 10840199527325 Elevator KOROS U.S.A., INC. HTE 2024-01-31 10840199527332 Elevator KOROS U.S.A., INC. HTE 2024-01-31 10840199527349 Elevator KOROS U.S.A., INC. HTE 2024-01-31 10840199527356 Elevator KOROS U.S.A., INC. HTE 2024-01-31 10840199528315 Elevator KOROS U.S.A., INC. HTE 2024-01-31 10840199529077 Comfort Plus Cobb Elevator KOROS U.S.A., INC. HTE 2024-01-31 10840199529084 Comfort Plus Cobb Elevator KOROS U.S.A., INC. HTE 2024-01-31 10840199529091 Comfort Plus Cobb Elevator KOROS U.S.A., INC. HTE 2024-01-31