PL-8 Cs-131 Brachytherapy Seeds Preloaded Strands in 18G Needles with MRI Marker

GUDID M748PL80

The Isoray Cesium-131 Implant Devices combined with MRI Markers will be used to facilitate the anatomical location of seeds after they have been implanted in the prostate of a patient with confirmed prostatic malignancy. The PL-8 device is preloaded strands with Markers in 18G needles.

ISORAY MEDICAL, INC.

General-purpose brachytherapy system applicator, manual

• Primary Device ID: M748PL80
• NIH Device Record Key: dfe9b8d5-bb43-49bd-a4b1-9b621716a1c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PL-8 Cs-131 Brachytherapy Seeds Preloaded Strands in 18G Needles with MRI Marker
• Version Model Number: PL-8
• Company DUNS: 113577485
• Company Name: ISORAY MEDICAL, INC.
• 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: 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

Customer Support Contacts

• Phone: 509-375-5329
• Email: customerservice@isoray.com
• Phone: 509-375-5329
• Email: customerservice@isoray.com
• Phone: 509-375-5329
• Email: customerservice@isoray.com
• Phone: 509-375-5329
• Email: customerservice@isoray.com
• Phone: 509-375-5329
• Email: customerservice@isoray.com
• Phone: 509-375-5329
• Email: customerservice@isoray.com
• Phone: 509-375-5329
• Email: customerservice@isoray.com
• Phone: 509-375-5329
• Email: customerservice@isoray.com
• Phone: 509-375-5329
• Email: customerservice@isoray.com
• Phone: 509-375-5329
• Email: customerservice@isoray.com
• Phone: 509-375-5329
• Email: customerservice@isoray.com
• Phone: 509-375-5329
• Email: customerservice@isoray.com
• Phone: 509-375-5329
• Email: customerservice@isoray.com
• Phone: 509-375-5329
• Email: customerservice@isoray.com
• Phone: 509-375-5329
• Email: customerservice@isoray.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M748PL80 [Primary]

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: 2021-05-03
• Device Publish Date: 2021-04-23

Devices Manufactured by ISORAY MEDICAL, INC.

• M748BBC10 - Blu Build Spacer Cartridge: 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