Blu Build Real Time Loader Device

GUDID M748BBL10

ISORAY MEDICAL, INC.

General-purpose brachytherapy system applicator, manual

• Primary Device ID: M748BBL10
• NIH Device Record Key: 22ca4f1c-aa7b-44f3-8521-f1d57d51e422
• Commercial Distribution Discontinuation: 2024-04-19
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Blu Build Real Time Loader Device
• Version Model Number: BBL-1
• Company DUNS: 113577485
• Company Name: ISORAY MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M748BBL10 [Primary]

FDA Product Code

• IWJ: System, Applicator, Radionuclide, Manual

Sterilization

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

[M748BBL10]

Ethylene Oxide

[M748BBL10]

Ethylene Oxide

[M748BBL10]

Ethylene Oxide

[M748BBL10]

Ethylene Oxide

[M748BBL10]

Ethylene Oxide

[M748BBL10]

Ethylene Oxide

[M748BBL10]

Ethylene Oxide

[M748BBL10]

Ethylene Oxide

[M748BBL10]

Ethylene Oxide

[M748BBL10]

Ethylene Oxide

[M748BBL10]

Ethylene Oxide

[M748BBL10]

Ethylene Oxide

[M748BBL10]

Ethylene Oxide

[M748BBL10]

Ethylene Oxide

[M748BBL10]

Ethylene Oxide

[M748BBL10]

Ethylene Oxide

[M748BBL10]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-04-23
• Device Publish Date: 2018-10-26

Devices Manufactured by ISORAY MEDICAL, INC.

• M748BBC10 - Blu Build Spacer Cartridge: 2024-04-23
• M748BBL10 - Blu Build Real Time Loader Device: 2024-04-23
• M748BBL10 - Blu Build Real Time Loader Device: 2024-04-23
• M748BBS10 - Blu Build Sleeve Carrier: 2024-04-23
• M748CS10 - Proxcelan™ Cs-131 Brachytherapy Seeds: 2024-04-23
• M748CS1NS0 - Proxcelan™ Cs-131 Brachytherapy Seeds: 2024-04-23
• M748PL10 - Proxcelan™ Cs-131 Strands: 2024-04-23
• M748PL20 - Proxcelan™ Cs-131 Preloaded Strands in 18G Needles: 2024-04-23
• M748PL30 - Proxcelan™ Cs-131 Preloaded 18G Needles: 2024-04-23