Home GUDID M7161011130 OrthoMedFlex
Primary DI M7161011130
Brand OrthoMedFlex
Company ORTHOMEDFLEX LLC
Model 101113
Catalog number 101-113
Device description Calcar Reamer, 45mm
Published 2019-02-15
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name LYS Bone Mill
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LYS Bone Mill Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M7161011130 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Bone-resection orthopaedic reamer, reusable An orthopaedic surgical instrument designed to resect bone (cut out part of the bone) and precisely shape a specific area of bone as it is advanced for the acceptance of a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna). Commonly called a mill or a reamer it is typically designed as either a preshaped or a solid cylindrical body with an end/circumferential cutting edge, and is attached to a shaft for manual or powered rotation. It is typically made of a high-grade stainless steel alloy in varying sizes. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 034442726 Device count 1 Premarket exempt true Lot or batch 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 B504BM54007010000 Stryker Provision LYS 2024-09-16 00889024675346 Z1™ Hip System Zimmer, Inc. LYS 2024-09-09 00889024675353 Z1™ Hip System Zimmer, Inc. LYS 2024-09-09 00889024675360 Z1™ Hip System Zimmer, Inc. LYS 2024-09-09 B504BMBM2100 Medtronic Provision LYS 2024-06-11 04047844121368 DIPLOMAT SIGNUS Medizintechnik GmbH LYS 2024-06-05 00842517106253 Karl Schumacher Karl Schumacher Dental, LLC LYS 2024-02-27 10603295516378 NA DEPUY ORTHOPAEDICS, INC. LYS 2024-01-15 00614950031252 ACE ACE SURGICAL SUPPLY CO., INC. LYS 2023-12-05 00888118142924 BONE MILL KLS-Martin L.P. LYS 2023-11-22 00888118142931 BONE MILL KLS-Martin L.P. LYS 2023-11-22 00888118142948 BONE MILL KLS-Martin L.P. LYS 2023-11-22 00888118142955 BONE MILL KLS-Martin L.P. LYS 2023-11-22 00888118142962 BONE MILL KLS-Martin L.P. LYS 2023-11-22 00841336103399 Salvin Dental Specialties SALVIN DENTAL SPECIALTIES, LLC LYS 2023-08-10 00841336103504 Salvin Dental Specialties SALVIN DENTAL SPECIALTIES, LLC LYS 2023-08-10 00888118142597 BONE MILL KLS-Martin L.P. LYS 2023-07-04 00888118142603 BONE MILL KLS-Martin L.P. LYS 2023-07-04 00888118142610 BONE MILL KLS-Martin L.P. LYS 2023-07-04 00888118142627 BONE MILL KLS-Martin L.P. LYS 2023-07-04 00888118142634 BONE MILL KLS-Martin L.P. LYS 2023-07-04 00888118142641 BONE MILL KLS-Martin L.P. LYS 2023-07-04 00888118142658 BONE MILL KLS-Martin L.P. LYS 2023-07-04 00190776264055 Avalign Avalign Technologies, Inc. LYS 2023-06-23 08720254007816 Sterilization tray NBM Spierings Orthopaedics B.V. LYS 2023-06-20 08720254007823 Housing Spierings Orthopaedics B.V. LYS 2023-06-20 08720254007830 Push Block Spierings Orthopaedics B.V. LYS 2023-06-20 08720254007847 Handle Spierings Orthopaedics B.V. LYS 2023-06-20 08720254007854 Screw nut Spierings Orthopaedics B.V. LYS 2023-06-20 08720254007861 Milling Drum Extra Extra Extra Fine Spierings Orthopaedics B.V. LYS 2023-06-20