Dolphin

GUDID EIBAE30620211

T2D Mini Elekta

IBA Dosimetry GmbH

Radiation electrometer

• Primary Device ID: EIBAE30620211
• NIH Device Record Key: 0be09915-a057-4de9-bb80-4751b9b17022
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dolphin
• Version Model Number: E3062021
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EIBAE30620210 [Primary]
HIBCC	EIBAE30620211 [Package]; Contains: EIBAE30620210; Package: Transport case [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072374

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

On-Brand Devices [Dolphin]

• EIBAE30620281: T2D Mini Elekta EU
• EIBAE30620271: T2D Mini Varian EU
• EIBAE30620251: T2D Mini Elekta Korea
• EIBAE30620241: T2D Mini Varian Korea
• EIBAE30620211: T2D Mini Elekta
• EIBAE30620201: T2D Mini Varian