Ru-106 Eye Applicator, type CCZ 6 MBq RU6.A01

GUDID 04049223100759

Eckert & Ziegler BEBIG GmbH

Manual brachytherapy source, temporary placement

• Primary Device ID: 04049223100759
• NIH Device Record Key: 425b4f2b-2003-4fb4-a00c-c819f920fdcb
• Commercial Distribution Discontinuation: 2020-06-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Ru-106 Eye Applicator, type CCZ 6 MBq
• Version Model Number: RU6.A01
• Catalog Number: RU6.A01
• Company DUNS: 331080432
• Company Name: Eckert & Ziegler BEBIG GmbH
• Device Count: 1
• DM Exempt: true
• 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: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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: +4930941084130
• Email: info@bebig.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Applicators must be stored in a dry state and with sufficient shielding in a locked safe. The Ru-106 eye applicator must not be stored in liquids or in the vicinity of media that promote corrosion.

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049223100759 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K931393

FDA Product Code

• KXK: Source, Brachytherapy, Radionuclide

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[04049223100759]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-07-01
• Device Publish Date: 2015-09-24

Devices Manufactured by Eckert & Ziegler BEBIG GmbH

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• 04049223100759 - Ru-106 Eye Applicator, type CCZ 6 MBq: 2020-07-01
• 04049223100759 - Ru-106 Eye Applicator, type CCZ 6 MBq: 2020-07-01
• 04049223100766 - Ru-106 Eye Applicator, type CCY 6 MBq: 2020-07-01
• 04049223100803 - Ru-106 Eye Applicator with slot, type CCA 10 MBq: 2020-07-01
• 04049223100827 - Ru-106 Eye Applicator with slot, type CCD 14 MBq: 2020-07-01
• 04049223100858 - Ru-106 Eye Applicator with slot, type CCB 19 MBq: 2020-07-01
• 04049223100872 - Ru-106 Eye Applicator with slot, type CGD 24 MBq: 2020-07-01