Advantage I-125

GUDID M936IRLS15SS9

Radioactive seed localization, seed and spacer

ISOAID, L.L.C.

Manual brachytherapy source, temporary placement

• Primary Device ID: M936IRLS15SS9
• NIH Device Record Key: 5340097b-1d96-4965-b0f6-58dde9d026e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Advantage I-125
• Version Model Number: RSLN-15SS
• Company DUNS: 002751241
• Company Name: ISOAID, L.L.C.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M936IRLS15SS9 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141701

FDA Product Code

• KXK: Source, Brachytherapy, Radionuclide

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-12
• Device Publish Date: 2025-03-04

On-Brand Devices [Advantage I-125]

• M936IRLS15SS9: Radioactive seed localization, seed and spacer
• M936IRLS15S9: Radioactive seed localization, seed only