selectSeed™ I-125 130002

GUDID 98717213037833

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

Nucletron B.V.

Remote-afterloading brachytherapy source Remote-afterloading brachytherapy source

• Primary Device ID: 98717213037833
• NIH Device Record Key: fa0885c5-5aaa-4fe3-bf22-fc109bddc59e
• Commercial Distribution Discontinuation: 2019-07-17
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: selectSeed™ I-125
• Version Model Number: 130002-01
• Catalog Number: 130002
• Company DUNS: 415269930
• Company Name: Nucletron B.V.
• Device Count: 100
• 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: true
• Lot Batch: true
• Serial Number: false
• 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: 770 300 9725
• Email: info.america@elekta.com
• Phone: 770 300 9725
• Email: info.america@elekta.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *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.
• Special Storage Condition, Specify: Between 0 and 0 *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.
• Special Storage Condition, Specify: Between 0 and 0 *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.
• Special Storage Condition, Specify: Between 0 and 0 *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.
• Special Storage Condition, Specify: Between 0 and 0 *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.
• Special Storage Condition, Specify: Between 0 and 0 *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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717213038066 [Unit of Use]
GS1	98717213037833 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002429

FDA Product Code

• KXK: Source, Brachytherapy, Radionuclide

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-07-17
• Device Publish Date: 2015-10-22

On-Brand Devices [selectSeed™ I-125]

• 98717213037840: Non-sterile IODINE—125 source for use with seedSelectron® for system verification. Not for h
• 98717213037833: Sterile IODINE—125 source for interstitial Brachytherapy for use with seedSelectron®. Quanti
• 08717213037854: Non-sterile IODINE—125 source for use with seedSelectron® for system calibration. Not for hu