emXX4Tera für Giraffe

GUDID EIBAE3055005V0010

IBA Dosimetry GmbH

Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device

• Primary Device ID: EIBAE3055005V0010
• NIH Device Record Key: 7124defb-81c3-48d8-8577-b555ac92be14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: emXX4Tera für Giraffe
• Version Model Number: E3055005#001
• Company DUNS: 332599307
• Company Name: IBA Dosimetry 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: false
• Serial Number: true
• 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

Customer Support Contacts

• Phone: +49912860738
• Email: service@iba-group.com
• Phone: +49912860738
• Email: service@iba-group.com
• Phone: +49912860738
• Email: service@iba-group.com
• Phone: +49912860738
• Email: service@iba-group.com
• Phone: +49912860738
• Email: service@iba-group.com
• Phone: +49912860738
• Email: service@iba-group.com
• Phone: +49912860738
• Email: service@iba-group.com
• Phone: +49912860738
• Email: service@iba-group.com
• Phone: +49912860738
• Email: service@iba-group.com
• Phone: +49912860738
• Email: service@iba-group.com
• Phone: +49912860738
• Email: service@iba-group.com
• Phone: +49912860738
• Email: service@iba-group.com
• Phone: +49912860738
• Email: service@iba-group.com
• Phone: +49912860738
• Email: service@iba-group.com
• Phone: +49912860738
• Email: service@iba-group.com
• Phone: +49912860738
• Email: service@iba-group.com
• Phone: +49912860738
• Email: service@iba-group.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EIBAE3055005V0010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092018

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-09

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• EIBAHA03010V0040 - Lift table: 2023-09-27 Electric Lift Table Type 115V
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• EIBAHA050100 - Water Reservoir: 2023-08-11 Waterreservoir - bidirectional pump, 115V
• EIBAE30702001 - myQA SRS Detector Cyberknife edition: 2023-08-02 myQA SRS Cyberknife edition
• EIBAE20702000 - DOSE-X: 2023-04-21 DOSE-X Dosimeter TNC
• EIBAE20703000 - DOSE-X: 2023-04-21 DOSE-X Dosimeter BNC