iGUIDE P10603-111

GUDID 04056719002039

iGUIDE® Software 2.2.2 is the software which controls the movement of the the HexaPOD™ evo Module and monitors the correct position of the module

Medical Intelligence Medizintechnik GmbH

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• Primary Device ID: 04056719002039
• NIH Device Record Key: c41547a9-cc71-4d45-aaa2-cbbe1a017b23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iGUIDE
• Version Model Number: P10603-111
• Catalog Number: P10603-111
• Company DUNS: 314546664
• Company Name: Medical Intelligence Medizintechnik GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056719002039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143485

FDA Product Code

• IYE: Accelerator, Linear, Medical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-17
• Device Publish Date: 2017-10-13

On-Brand Devices [iGUIDE]

• 04056719002039: iGUIDE® Software 2.2.2 is the software which controls the movement of the the HexaPOD™ evo M
• 04056719001742: iGUIDE® Software 2.2.1 is the software which controls the movement of the HexaPOD™ evo Module
• 04056719001704: iGUIDE® Software 2.2 is the software which controls the movement of the the HexaPOD™ evo Mod
• 04056719001674: iGUIDE Reference Frame Set used by iGUIDE Software to control position of HexaPOD evo