Shoulder System Instrument

GUDID 07630345738967

Bipolar Head Tray Endohead

Medacta International SA

Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 07630345738967
• NIH Device Record Key: 7ce057be-09a4-445e-b79d-d3266ead6ff3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shoulder System Instrument
• Version Model Number: 01.08.10.0300
• Company DUNS: 488227125
• Company Name: Medacta International SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630345738967 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[07630345738967]

Moist Heat or Steam Sterilization

[07630345738967]

Moist Heat or Steam Sterilization

[07630345738967]

Moist Heat or Steam Sterilization

[07630345738967]

Moist Heat or Steam Sterilization

[07630345738967]

Moist Heat or Steam Sterilization

[07630345738967]

Moist Heat or Steam Sterilization

[07630345738967]

Moist Heat or Steam Sterilization

[07630345738967]

Moist Heat or Steam Sterilization

[07630345738967]

Moist Heat or Steam Sterilization

[07630345738967]

Moist Heat or Steam Sterilization

[07630345738967]

Moist Heat or Steam Sterilization

[07630345738967]

Moist Heat or Steam Sterilization

[07630345738967]

Moist Heat or Steam Sterilization

[07630345738967]

Moist Heat or Steam Sterilization

[07630345738967]

Moist Heat or Steam Sterilization

[07630345738967]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-12
• Device Publish Date: 2021-10-04

On-Brand Devices [Shoulder System Instrument]

• 07630971248434: Backtable long stem adapter – 6
• 07630971234000: Trial humeral diaphysis - Ø15
• 07630971233997: Trial humeral diaphysis - Ø14
• 07630971233980: Trial humeral diaphysis - Ø13
• 07630971233973: Trial humeral diaphysis - Ø12
• 07630971233966: Trial humeral diaphysis - Ø11
• 07630971233959: Trial humeral diaphysis - Ø10
• 07630971233942: Trial humeral diaphysis - Ø9
• 07630971233935: Trial humeral diaphysis - Ø8
• 07630971233928: Trial humeral diaphysis - Ø7
• 07630971233911: Trial humeral diaphysis - Ø6
• 07630971233904: HEX 3.5 retentive screwdriver
• 07630971233898: Trial glenosphere - Ø42
• 07630971233881: Trial glenosphere - Ø39
• 07630971233874: Trial glenosphere - Ø36
• 07630971233867: Trial glenosphere - Ø32
• 07630971233850: Torque limiting screwdriver T20 6Nm
• 07630971233843: Torque limiting screwdriver T15 3Nm
• 07630971233836: Torque limiting screwdriver T10 2Nm
• 07630971233829: Glenoid polyaxial screwdriver
• 07630971233799: Drill guide for glenoid polyaxial screws
• 07630971233782: Impactor handle
• 07630971233775: Baseplate impactor tip - Ø27
• 07630971233768: Baseplate impactor tip - Ø24.5
• 07630971233751: Baseplate impactor tip - Ø22
• 07630971233744: M5 fixation rod
• 07630971233720: Reamer for glenosphere - Ø42
• 07630971233713: Reamer for glenosphere - Ø39
• 07630971209985: Reamer for glenosphere - Ø36
• 07630971209978: Reamer for glenosphere - Ø32
• 07630971209923: Glenoid multi-purpose handle
• 07630971209916: Reverse glenoid aiming device - 39-42
• 07630971209909: Reverse glenoid aiming device - 32-36
• 07630971209893: Humeral cut protector L
• 07630971209886: Humeral cut protector M
• 07630971209879: Humeral cut protector S
• 07630971209862: Humeral broach handle
• 07630971209855: Humeral standard broach - Ø16
• 07630971209848: Humeral standard broach - Ø15
• 07630971209831: Humeral standard broach - Ø14
• 07630971209824: Humeral standard broach - Ø13
• 07630971209817: Humeral standard broach - Ø12
• 07630971209800: Humeral standard broach - Ø11
• 07630971209794: Humeral standard broach - Ø10
• 07630971209787: Humeral standard broach - Ø9
• 07630971209770: Humeral standard broach - Ø8
• 07630971209763: Humeral standard broach - Ø7
• 07630971209756: Humeral standard broach - Ø6
• 07630971209749: Metaphyseal chisel
• 07630971209619: Retroversion rod