emXX4Tera für Giraffe

GUDID EIBAE3055005V0010

IBA Dosimetry GmbH

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
• EIBAHA050000 - Water Reservoir: 2023-08-11 Waterreservoir - bidirectional pump, 230V
• 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