Home GUDID 09120047297223 Handle, Left
Primary DI 09120047297223
Brand Handle, Left
Company I.T.S. GmbH
Model 118003-4
Catalog number 118003-4
Device description Handle, Left, Distal Femur Plate
Published 2018-10-18
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 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 09120047297223 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 09120047297223 09120047297223 9120047297223
GMDN Terms# Term, Definition table Term Definition Orthopaedic implant aiming arm A surgical jig-like device designed as a precision guide for the pre-drilling of orthopaedic screw holes into bone and for guiding an orthopaedic instrument into an implanted device, typically to treat long bones (e.g., femur, humerus, and tibia). It typically consists of two parts in one-piece or modular configurations: 1) an insertion guide in which the correctly angled/placed guide holes are situated; and 2) an insertion handle which will attach to the bone or implant. Drill guides or other drilling/tapping devices will be fed through the insertion guide at the precise intended angle, and it may have adaptations for providing magnetic alignment. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 303456917 Device count 1 Premarket exempt true Lot or batch true Serial number true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 09120116973843 Impactor 1UI105A 1UI105A 2024-08-05 09120116973850 PF Extension Endcap,+5mm, PPS 1F0-15-05A-S 1F0-15-05A-S 2024-08-05 09120116973874 PF Extension Endcap,+10mm, PPS 1F0-15-10A-S 1F0-15-10A-S 2024-08-05 09120116973881 PF Extension Endcap,+15mm, PPS 1F0-15-15A-S 1F0-15-15A-S 2024-08-05 09120116973898 PF Extension Endcap,+20mm, PPS 1F0-15-20A-S 1F0-15-20A-S 2024-08-05 09120116973867 PF Endcap, 0mm PPS 1F0-10-30A-S 1F0-10-30A-S 2024-04-15 09120034300417 Bending Iron 66252-14 66252-14 2018-11-08 09120034306419 Small Plate Bending Iron KM 47-915 KM 47-915 2018-11-13 09120034306426 Small Plate Bending Iron KM 47-916 KM 47-916 2018-11-13 09120047301883 Bending Heaver KJ.206.14 KJ.206.14 2018-11-14 09120047301890 Bending Heaver KJ.207.14 KJ.207.14 2018-11-14 09120069815429 In-Situ Bending Iron 66261 66261 2018-11-08 09120069815436 In-Situ Bending Iron 66262 66262 2018-11-08 09120069815443 In-Situ Bending Iron 66263 66263 2018-11-08 09120034302626 Fibula Plate PROlock 21222-8 21222-8 2016-09-08 09120034302633 Fibula Plate PROlock 21222-6 21222-6 2016-09-08 09120034302640 Fibula Plate PROlock 21222-4 21222-4 2016-09-08 09120034302657 Fibula Plate PROlock 21221-8 21221-8 2016-09-08 09120034302664 Fibula Plate PROlock 21221-6 21221-6 2016-09-08 09120034302671 Fibula Plate PROlock 21221-4 21221-4 2016-09-08
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