WP1D

GUDID EIBAM90061200

WP1D motorized water phantom including Smart Control Unit (SCU)

IBA Dosimetry GmbH

Accelerator system quality assurance device

• Primary Device ID: EIBAM90061200
• NIH Device Record Key: 03a328dc-cae9-400e-a8fa-3430f2ad7acc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WP1D
• Version Model Number: M9006120
• 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: 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

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EIBAM90061200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032594

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: 2018-07-06
• Device Publish Date: 2016-09-09

On-Brand Devices [WP1D]

• EIBAM90061200: WP1D motorized water phantom including Smart Control Unit (SCU)
• EIBAM90061100: WP1D motorized water phantom with interface to CU500E
• EIBAM9006100V0010: WP1D manual water phantom