Proxcelan™ Cs-131 Preloaded Braided Strands

GUDID M748PL5M0

ISORAY MEDICAL, INC.

General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual

• Primary Device ID: M748PL5M0
• NIH Device Record Key: 49e69833-c881-4345-bf32-d9498a447e2d
• Commercial Distribution Discontinuation: 2024-04-19
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Proxcelan™ Cs-131 Preloaded Braided Strands
• Version Model Number: PL-5M
• Company DUNS: 113577485
• Company Name: ISORAY MEDICAL, INC.
• Device Count: 1
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M748PL5M0 [Primary]

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: 4
• Public Version Date: 2024-04-23
• Device Publish Date: 2015-10-28

On-Brand Devices [Proxcelan™ Cs-131 Preloaded Braided Strands]

• M748PL5M0: PL-5M
• M748PL50: PL-5