Home GUDID 18054242510550 CONTOURS PROXIMAL HUMERAL PLATE (PHP) & LSP TITANIUM HUMERAL PLATE
Primary DI 18054242510550
Brand CONTOURS PROXIMAL HUMERAL PLATE (PHP) & LSP TITANIUM HUMERAL PLATE
Company ORTHOFIX SRL
Model 1
Catalog number TP1100
Device description DRILL GUIDE (D. 3.2MM)
Published 2018-04-20
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Product Codes# Code, Name table Code Name KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 18054242510550 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 18054242510550 18054242510550
GMDN Terms# Term, Definition table Term Definition Surgical drill guide, reusable A manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.
Device Sizes# Type, Value, Unit table Type Value Unit Outer Diameter 3.2 Millimeter
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 438793622 Device count 1 Lot or batch true Manufacturing date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 18059015375831 OrthoNext™ Platform System Software 2.1 ORTHONEXTSW2.1 2025-01-31 18059015375848 OrthoNext™ Platform System Software 1.1 TLHEXMODULESW1.1 2025-01-31 18052469476444 OrthoNext™ Platform System Software 1.0 TLHEXMODULESW 2023-03-31 18052469476451 OrthoNext™ Platform System Software 1.0 MYHEXPLANSW 2023-03-31 18053340345675 OrthoNext™ Platform System Software 2.0 ORTHONEXTSW 2023-03-31 18053340345682 OrthoNext™ Platform System Software 1.1 JPSMODULESW 2023-03-31 18032568033229 Surgical Instruments 1 13620 2026-07-23 18032568033236 Surgical Instruments 1 13621 2026-07-23 18032568036008 WRIST FIXATION SYSTEMS 1 36008 2026-07-23 18059015376838 Fitbone Transport and Lengthening System 1 99-60003817 2026-07-23 18059015376845 Fitbone Transport and Lengthening System 1 99-60003818 2026-07-23 18059015376852 Fitbone Transport and Lengthening System 1 99-60003819 2026-07-23 18059015376869 Fitbone Transport and Lengthening System 1 99-60003820 2026-07-23 18059015376876 Fitbone Transport and Lengthening System 1 99-60003821 2026-07-23 18059015376883 Fitbone Transport and Lengthening System 1 99-60003822 2026-07-23 18059015376890 Fitbone Transport and Lengthening System 1 99-60003823 2026-07-23 18059015376906 Fitbone Transport and Lengthening System 1 99-60003824 2026-07-23 18059015376913 Fitbone Transport and Lengthening System 1 99-60003825 2026-07-23 18059015376920 Fitbone Transport and Lengthening System 1 99-60003826 2026-07-23 18059015376937 Fitbone Transport and Lengthening System 1 99-60003827 2026-07-23
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