Home GUDID M7161124411080
OrthoMedFlex
Primary DI M7161124411080
Brand OrthoMedFlex
Company ORTHOMEDFLEX LLC
Model 112-44-1108
Device description Origin R Broach Size 8
Published 2021-11-03
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 HTQ Broach
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HTQ Broach Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M7161124411080 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Orthopaedic implant impactor A metal and/or plastic hand-held manual surgical instrument designed to position an implant into the body. Its mode of application is by transmission of an impact force to drive the implant into its final position in the body. The proximal end is a handle usually designed to absorb the impact from a surgical hammer or mallet. The distal end is usually shaped to conform to the implant shape, which could be flat or anatomically curved, or shaped like a chisel handle to facilitate the positioning. 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 10603295079965 AML EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080176 EXCEL TRI-LOCK DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080183 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080190 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080206 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080213 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080220 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080237 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080244 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080251 NA DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080268 NA DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080275 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080282 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080299 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080305 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080312 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080329 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080336 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080343 NA DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080350 NA DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080367 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080374 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080381 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295082057 TRI-LOCK DEPUY (IRELAND) HTQ 2018-09-24 10603295082064 TRI-LOCK DEPUY (IRELAND) HTQ 2018-09-24 10603295082071 TRI-LOCK DEPUY (IRELAND) HTQ 2018-09-24 10603295082088 TRI-LOCK DEPUY (IRELAND) HTQ 2018-09-24 10603295082095 TRI-LOCK DEPUY (IRELAND) HTQ 2018-09-24 10603295082101 TRI-LOCK DEPUY (IRELAND) HTQ 2018-09-24 10603295082118 TRI-LOCK DEPUY (IRELAND) HTQ 2018-09-24