Home GUDID 00840118118378 Removal Tool, 3.5mm
Primary DI 00840118118378
Brand Removal Tool, 3.5mm
Company FLOWER ORTHOPEDICS CORPORATION
Model EZO 135
Device description Orthopaedic implant reamer
Published 2022-01-14
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile 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 00840118118378 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 00840118118378 00840118118378 840118118378 0840118118378
GMDN Terms# Term, Definition table Term Definition Orthopaedic implant reamer A surgical tool designed to over-drill a cylindrical orthopaedic implant (screw, pin, intrameduallry nail) to facilitate its removal by excising overgrown bone or other tissue. It is in the form of a hollow fluted metal shaft, with saw teeth at the cutting edge, available in a variety of sizes to match the different sizes of implant. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Length 200 Millimeter Outer Diameter 3.5 Millimeter
Regulatory Flags# DUNS number 078790947 Device count 1 DM exempt true Premarket exempt true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00840118126199 Active Compression OTP055 2025-12-01 00840118126298 Active Compression SHADP 2025-12-01 00840118126526 Active Compression OC70120 2025-12-01 00840118116800 ZERO Profile Interlocking Cortex Screw, 3.5mm x 10mm, T15, Flex-Thread™ 8525-10-S 2021-03-19 00840118116817 ZERO Profile Interlocking Cortex Screw, 3.5mm x 12mm, T15, Flex-Thread™ 8525-12-S 2021-03-19 00840118116824 ZERO Profile Interlocking Cortex Screw, 3.5mm x 14mm, T15, Flex-Thread™ 8525-14-S 2021-03-19 00840118116831 ZERO Profile Interlocking Cortex Screw, 3.5mm x 16mm, T15, Flex-Thread™ 8525-16-S 2021-03-19 00840118116848 ZERO Profile Interlocking Cortex Screw, 3.5mm x 18mm, T15, Flex-Thread™ 8525-18-S 2021-03-19 00840118116855 ZERO Profile Interlocking Cortex Screw, 3.5mm x 20mm, T15, Flex-Thread™ 8525-20-S 2021-03-19 00840118116862 ZERO Profile Interlocking Cortex Screw, 3.5mm x 22mm, T15, Flex-Thread™ 8525-22-S 2021-03-19 00840118116879 ZERO Profile Interlocking Cortex Screw, 3.5mm x 24mm, T15, Flex-Thread™ 8525-24-S 2021-03-19 00840118116886 ZERO Profile Interlocking Cortex Screw, 3.5mm x 26mm, T15, Flex-Thread™ 8525-26-S 2021-03-19 00840118116893 ZERO Profile Interlocking Cortex Screw, 3.5mm x 28mm, T15, Flex-Thread™ 8525-28-S 2021-03-19 00840118116909 ZERO Profile Interlocking Cortex Screw, 3.5mm x 30mm, T15, Flex-Thread™ 8525-30-S 2021-03-19 00840118116916 ZERO Profile Interlocking Cortex Screw, 3.5mm x 32mm, T15, Flex-Thread™ 8525-32-S 2021-03-19 00840118116923 ZERO Profile Interlocking Cortex Screw, 3.5mm x 34mm, T15, Flex-Thread™ 8525-34-S 2021-03-19 00840118116930 ZERO Profile Interlocking Cortex Screw, 3.5mm x 36mm, T15, Flex-Thread™ 8525-36-S 2021-03-19 00840118116947 ZERO Profile Interlocking Cortex Screw, 3.5mm x 38mm, T15, Flex-Thread™ 8525-38-S 2021-03-19 00840118116954 ZERO Profile Interlocking Cortex Screw, 3.5mm x 40mm, T15, Flex-Thread™ 8525-40-S 2021-03-19 00840118116961 ZERO Profile Interlocking Cortex Screw, 3.5mm x 42mm, T15, Flex-Thread™ 8525-42-S 2021-03-19
Other Devices Sharing Product Codes#