Home GUDID 09120047305485 Plate Holder
Primary DI 09120047305485
Brand Plate Holder
Company I.T.S. GmbH
Model 58100-100
Catalog number 58100-100
Device description Plate Holder
Published 2018-11-07
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 HXK Holder, Needle; Orthopedic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HXK Holder, Needle; Orthopedic Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 09120047305485 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 09120047305485 09120047305485 9120047305485
GMDN Terms# Term, Definition table Term Definition Orthopaedic prosthesis implantation positioning instrument, reusable A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. 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 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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