Home GUDID M7161011380 OrthoMedFlex
Primary DI M7161011380
Brand OrthoMedFlex
Company ORTHOMEDFLEX LLC
Model 101-138
Catalog number 101-138
Device description Trochanteric Reamer
Published 2016-08-30
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 M7161011380 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Medullary canal orthopaedic reamer, rigid An orthopaedic surgical instrument designed to open and enlarge the medullary canal (e.g., in the femur, tibia, ulnar) for the insertion of various devices during prosthesis implantation or fracture fixation procedures. It is typically designed as a long, cylindrical, rigid shaft with straight, spiralled, or contoured flutes that function as cutting surfaces; it may include a transverse milling (spotfacing) burr to level the end of the bone (e.g., post amputation). It is typically made of a high-grade stainless steel and is available in various sizes. It is intended for manual or powered rotation. This is a reusable device intended to be sterilized prior to use.
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
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