IsoSeed® I-125, unsterile, loose, high activity

GUDID 04049223117184

Ophth. seeds, unsterile, loose, high activity

Eckert & Ziegler BEBIG GmbH

Manual brachytherapy source, permanent implant

• Primary Device ID: 04049223117184
• NIH Device Record Key: fc42ddc3-abe5-459b-b014-41e5fdbc42ce
• Commercial Distribution Discontinuation: 2016-09-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: IsoSeed® I-125, unsterile, loose, high activity
• Version Model Number: I25.S17PLUS-ULH
• Company DUNS: 331080432
• Company Name: Eckert & Ziegler BEBIG 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049223117184 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140849

FDA Product Code

• KXK: Source, Brachytherapy, Radionuclide

Sterilization

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

[04049223117184]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

Devices Manufactured by Eckert & Ziegler BEBIG GmbH

• 04049223104047 - Opening Forceps for Holding Discs: 2020-12-29
• 04049223132088 - SagiPlan® 2.x Software: 2020-07-09
• 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