Advantage I-125® RSLN

GUDID M936IRLS20SSS0

Radioactive Seed Localization with I-125 seed, spacer, strand. 20 cm Needle

ISOAID, L.L.C.

Manual brachytherapy source, temporary placement

• Primary Device ID: M936IRLS20SSS0
• NIH Device Record Key: d24b00b1-f93f-48d7-96fd-8f0b55fa10a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Advantage I-125®
• Version Model Number: RSLN-20
• Catalog Number: RSLN
• 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	M936IRLS20SSS0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141701

FDA Product Code

• KXK: Source, Brachytherapy, Radionuclide

Sterilization

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

[M936IRLS20SSS0]

Ethylene Oxide

[M936IRLS20SSS0]

Ethylene Oxide

[M936IRLS20SSS0]

Ethylene Oxide

[M936IRLS20SSS0]

Ethylene Oxide

[M936IRLS20SSS0]

Ethylene Oxide

[M936IRLS20SSS0]

Ethylene Oxide

[M936IRLS20SSS0]

Ethylene Oxide

[M936IRLS20SSS0]

Ethylene Oxide

[M936IRLS20SSS0]

Ethylene Oxide

[M936IRLS20SSS0]

Ethylene Oxide

[M936IRLS20SSS0]

Ethylene Oxide

[M936IRLS20SSS0]

Ethylene Oxide

[M936IRLS20SSS0]

Ethylene Oxide

[M936IRLS20SSS0]

Ethylene Oxide

[M936IRLS20SSS0]

Ethylene Oxide

[M936IRLS20SSS0]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-15
• Device Publish Date: 2022-02-07

On-Brand Devices [Advantage I-125®]

• M936IRLS20SSS0: Radioactive Seed Localization with I-125 seed, spacer, strand. 20 cm Needle
• M936IRLS20: Radioactive Seed Localization with I-125 seed, spacer, strand. 20 cm Needle
• M936IRLS20SS0: Radioactive Seed Localization with I-125 seed, spacer, strand. 20 cm Needle
• M936IRLS20S0: Radioactive Seed Localization with I-125 seed, spacer, strand. 20 cm Needle
• M936IBKSSAL9: Secure Strand and Advantage Load with I-125 radioactive seeds.