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

Basic Information

• Brand Name: PL-8 Cs-131 Brachytherapy Seeds Preloaded Strands in 18G Needles with MRI Marker
• Primary DI: M748PL80
• Version / Model: PL-8
• Company Name: ISORAY MEDICAL, INC.
• Labeler DUNS: 113577485
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-23
• Public Version: 2
• Public Version Date: 2024-04-23
• Public Version Status: Update
• Public Device Record Key: dfe9b8d5-bb43-49bd-a4b1-9b621716a1c8
• Distribution End Date: 2024-04-19

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KXK	Source, Brachytherapy, Radionuclide	Radiology	892.5730	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38435	General-purpose brachytherapy system applicator, manual	A general-purpose brachytherapy applicator designed to facilitate delivery of radiation therapy treatments that are not specific to a particular anatomical region. It is an individual or modular device designed to facilitate manual placement, e.g., puncture, topical placement, endoscopically guided placement or diagnostic imaging system guided placement, and removal of single or multiple radioactive sources at a treatment site. The device may be a fixed design or designed to facilitate the creation of variable physical configurations or individual patient source placement configurations and includes general-purpose applicators such as hollow needles, tubes or catheters, ovoids or tandems.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M748PL80	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]