Bard® BrachySource® I-125 Implant Seed Preloaded in Needles

Basic Information

• Brand Name: Bard® BrachySource® I-125 Implant Seed Preloaded in Needles
• Primary DI: 00801741098598
• Version / Model: 1251LINK
• Catalog Number: 1251LINK
• Company Name: Bard Brachytherapy, Inc.
• Labeler DUNS: 185524860
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-05
• Public Version: 3
• Public Version Date: 2020-11-02
• Public Version Status: Update
• Public Device Record Key: a52e4c6b-3d7d-492b-bd4f-5f0fa0cc5f22

Device Description

Preloaded Needle Kits all consist of products (BrachySource® Iodine seeds, SourceLink™, Spacers) loaded into Brachytherapy needles

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
33069	Brachytherapy needle	A sterile, sharp bevel-edged, hollow tubular metal instrument that is used to inject radionuclide into a body cavity or tissue as a source of nuclear radiation for cancer therapy (brachytherapy). The device may be pre-sterilized and preloaded, and may have a tip enhanced for ultrasound-guided implantation. This is a single-use device.	No	Active
38303	Manual brachytherapy source, permanent implant	A device that is a naturally-occurring, accelerator- or reactor-produced radioactive isotope and intended to be permanently implanted into the body in order to deliver curative or palliative radiotherapy treatments. It is typically placed in the body by means of an applicator using either fluoroscopic or endoscopic guidance. Manually implanted sources intended for permanent implantation are designed to be histocompatible. It may take the form of, e.g., microspheres, spheres, stents, seeds or wires selected for producing low energy photons, beta or alpha particles.	Yes	Active
46844	Brachytherapy source spacer	A sterile, bioabsorbable device designed to separate radioactive sources of the seed type that are permanently implanted in close proximity to a selected localized tumour, to increase the distribution of radioactivity to the tumour. It typically has a cylindrical form (of around 0.5 cm in length and less than 1 mm in diameter) and is made of bioabsorbable polymer materials. It may be used for the primary treatment of tumours (e.g., prostate cancer), or to treat unresectable tumours, recurring tumours, or residual disease. It is typically placed in the body by means of a remote-afterloading applicator using ultrasonic or fluoroscopic guidance.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00801741098598	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K093663	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: 40 Degrees Celsius