Calcshift Instrument System

GUDID 00810082898378

CalcShift Burr Guide

Medartis Inc.

Orthopaedic prosthesis implantation positioning instrument, single-use

• Primary Device ID: 00810082898378
• NIH Device Record Key: f06a1edf-4c75-43ac-b1d3-f2465ff2ee5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Calcshift Instrument System
• Version Model Number: 1031-10014
• Company DUNS: 192756786
• Company Name: Medartis Inc.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	00810082898378 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00810082898378]

Moist Heat or Steam Sterilization

[00810082898378]

Moist Heat or Steam Sterilization

[00810082898378]

Moist Heat or Steam Sterilization

[00810082898378]

Moist Heat or Steam Sterilization

[00810082898378]

Moist Heat or Steam Sterilization

[00810082898378]

Moist Heat or Steam Sterilization

[00810082898378]

Moist Heat or Steam Sterilization

[00810082898378]

Moist Heat or Steam Sterilization

[00810082898378]

Moist Heat or Steam Sterilization

[00810082898378]

Moist Heat or Steam Sterilization

[00810082898378]

Moist Heat or Steam Sterilization

[00810082898378]

Moist Heat or Steam Sterilization

[00810082898378]

Moist Heat or Steam Sterilization

[00810082898378]

Moist Heat or Steam Sterilization

[00810082898378]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-05
• Device Publish Date: 2024-11-27

On-Brand Devices [Calcshift Instrument System]

• 00810082898187: CalcShift Instrument Kit Lid
• 00817701029472: Black Agile Mini AO Ratchet Handle
• 00810082898538: CalcShift Threaded Wire Caddy
• 00810082898521: CalcShift Wire Caddy
• 00810082898392: CalcShift Driver
• 00810082898385: CalcShift Mini Osteotome
• 00810082898378: CalcShift Burr Guide
• 00810082898354: CalcShift Burr
• 00810082898330: CalcShift 2.2mm Targeting Arm
• 00810082898323: CalcShift 1.6mm Targeting Arm
• 00810082898316: CalcShift Locking Nut
• 00810082898309: CalcShift Positioning Frame Push Screw
• 00810082898293: CalcShift Positioning Frame Rail Screw
• 00810082898286: CalcShift Positioning Frame Connector
• 00810082898279: CalcShift Positioning Frame Push
• 00810082898262: CalcShift Positioning Frame Rail
• 00810082898255: CalcShift Cutting Guide
• 00810082898231: CalcShift Threaded Wire
• 00810082898217: CalcShift Wire
• 00810082898200: CalcShift Wire Guide
• 00810082898194: CalcShift Instrument Kit Tray