Home GUDID B8039702640 ORTHOMED
Primary DI B8039702640
Brand ORTHOMED
Company ORTHO-MED, INC.
Model OM 97-0264
Device description RHOTON ELEVATOR TITANIUM 190MM ANGLED
Published 2026-06-22
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false 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 B8039702640 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 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false 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 00198506091919 ELMED INCORPORATED ELMED INCORPORATED HTE 2026-07-22 10705034579580 N/A Medos International Sàrl HTE 2026-06-25 10705034579597 N/A Medos International Sàrl HTE 2026-06-25 10705034579603 N/A Medos International Sàrl HTE 2026-06-25 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