emXX4Tera für Zebra

GUDID EIBAE3055000V0010

IBA Dosimetry GmbH

Accelerator system quality assurance device

• Primary Device ID: EIBAE3055000V0010
• NIH Device Record Key: 740b42ea-cd15-4dd8-910c-b36b6bd320eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: emXX4Tera für Zebra
• Version Model Number: E3055000#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: +1 901 386-2242
• Email: USService@iba-group.com
• Phone: +1 901 386-2242
• Email: USService@iba-group.com
• Phone: +1 901 386-2242
• Email: USService@iba-group.com
• Phone: +1 901 386-2242
• Email: USService@iba-group.com
• Phone: +1 901 386-2242
• Email: USService@iba-group.com
• Phone: +1 901 386-2242
• Email: USService@iba-group.com
• Phone: +1 901 386-2242
• Email: USService@iba-group.com
• Phone: +1 901 386-2242
• Email: USService@iba-group.com
• Phone: +1 901 386-2242
• Email: USService@iba-group.com
• Phone: +1 901 386-2242
• Email: USService@iba-group.com
• Phone: +1 901 386-2242
• Email: USService@iba-group.com
• Phone: +1 901 386-2242
• Email: USService@iba-group.com
• Phone: +1 901 386-2242
• Email: USService@iba-group.com
• Phone: +1 901 386-2242
• Email: USService@iba-group.com
• Phone: +1 901 386-2242
• Email: USService@iba-group.com
• Phone: +1 901 386-2242
• Email: USService@iba-group.com
• Phone: +1 901 386-2242
• Email: USService@iba-group.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EIBAE3055000V0010 [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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