selectSeed™ I-125

Basic Information

• Brand Name: selectSeed™ I-125
• Primary DI: 98717213037833
• Version / Model: 130002-01
• Catalog Number: 130002
• Company Name: Nucletron B.V.
• Labeler DUNS: 415269930
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2015-10-22
• Public Version: 5
• Public Version Date: 2019-07-17
• Public Version Status: Update
• Public Device Record Key: fa0885c5-5aaa-4fe3-bf22-fc109bddc59e
• Distribution End Date: 2019-07-17

Device Description

Sterile IODINE—125 source for interstitial Brachytherapy for use with seedSelectron®. Quantity in package is customer order specific in range 10 – 100 seeds.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KXK	Source, Brachytherapy, Radionuclide	Radiology	892.5730	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38302	Remote-afterloading brachytherapy source	A device that is a naturally-occurring, accelerator or reactor produced-radioactive isotope used as a source of radiation in high or low dose rate remote afterloading brachytherapy systems designed to deliver curative or palliative radiotherapy treatments. Sources used in remote afterloading radiotherapy systems may come in a variety of strengths and physical forms, e.g., single encapsulated source (sealed source), ribbons, plated, foil or embedded sources or contained radioactive liquids or gels. It is typically housed in a shielded safe within the remote afterloading system and delivered through guide tubes or catheters to the treatment site by various remote-controlled mechanisms.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	98717213037833	GS1
Unit of Use	08717213038066	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K002429	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 158 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Storage of selectSeeds™ I-125 has to be in a place with adequate radiation protection that is safe from unauthorized access, in accordance with the regulations of radionuclide laboratories.