Advantage-Strand® with Advantage I-125®

GUDID M936IBKAS9

Brachytherapy Kit: Advantage-Strand® with I-125 radioactive seeds.

ISOAID, L.L.C.

Brachytherapy injection needle

• Primary Device ID: M936IBKAS9
• NIH Device Record Key: 6c34e7b2-f09c-4fec-bc50-55abe60e027e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Advantage-Strand® with Advantage I-125®
• Version Model Number: IBKA
• Company DUNS: 002751241
• Company Name: ISOAID, L.L.C.
• Device Count: 9
• DM Exempt: true
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M936IBKAS [Unit of Use]
HIBCC	M936IBKAS9 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091117

FDA Product Code

• KXK: Source, Brachytherapy, Radionuclide

Sterilization

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

[M936IBKAS9]

Ethylene Oxide

[M936IBKAS9]

Ethylene Oxide

[M936IBKAS9]

Ethylene Oxide

[M936IBKAS9]

Ethylene Oxide

[M936IBKAS9]

Ethylene Oxide

[M936IBKAS9]

Ethylene Oxide

[M936IBKAS9]

Ethylene Oxide

[M936IBKAS9]

Ethylene Oxide

[M936IBKAS9]

Ethylene Oxide

[M936IBKAS9]

Ethylene Oxide

[M936IBKAS9]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-05-03
• Device Publish Date: 2016-02-04

Devices Manufactured by ISOAID, L.L.C.

• M936IBKAL9 - Advantage-Load® with Advantage I-125®: 2024-05-03 Advantage-Load® with I-125 radioactive seeds.
• M936IBKAS9 - Advantage-Strand® with Advantage I-125®: 2024-05-03Brachytherapy Kit: Advantage-Strand® with I-125 radioactive seeds.
• M936IBKAS9 - Advantage-Strand® with Advantage I-125®: 2024-05-03 Brachytherapy Kit: Advantage-Strand® with I-125 radioactive seeds.
• M936IBKASAL9 - Advantage-Strand® and Advantage-Load® with Advantage I-125®: 2024-05-03 Brachytherapy Kit: Advantage-Strand® and Advantage-Load® with Advantage I-125® radioactive seeds.
• M936IBKSS9 - Secure Strand® with Advantage I-125®: 2024-05-03 Secure Strand with I-125 radioactive seeds.
• M936IBKSSAL9 - Advantage I-125®: 2024-05-03 Secure Strand and Advantage Load with I-125 radioactive seeds.
• M936PBKAL9 - Advantage-Load® with Advantage Pd-103®: 2024-05-03 Advantage-Load® with Advantage Pd-103® radioactive seeds.
• M936PBKAS9 - Advantage-Strand® with Advantage Pd-103®: 2024-05-03 Advantage-Strand® with Advantage Pd-103® radioactive seeds.
• M936PBKASAL9 - Advantage-Strand® and Advantage-Load® and Advantage Pd-103®: 2024-05-03 Brachytherapy Kit: Advantage-Strand and Advantage-Load with Pd-103 radioactive seeds.