Beacon Care Package - Soft Tissue (17G)

Basic Information

• Brand Name: Beacon Care Package - Soft Tissue (17G)
• Primary DI: 00850011006047
• Version / Model: ASM0607-001
• Catalog Number: ASM0607-001
• Company Name: VARIAN MEDICAL SYSTEMS, INC.
• Labeler DUNS: 070809675
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-01-21
• Public Version: 4
• Public Version Date: 2021-08-24
• Public Version Status: Update
• Public Device Record Key: 6e7abbc8-b066-44cc-84ef-2ed9f09d6847

Device Description

The Beacon transponder is an implantable wireless device composed of an internal circuit and encapsulation materials. The internal circuit resonates in response to an external AC magnetic field. The Beacon Care package consists of three Beacon transponders, each with a dedicated introducer needle. The Beacon transponders are implanted in or near the treatment target. The resonance signal is used to measure the location of the transponder, by the Calypso System. The BCP-Soft Tissue many only be used with the Calypso System v3.0 or higher.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: 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
IYE	Accelerator, Linear, Medical	Radiology	892.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46467	Radiation therapy invasive marker lesion localization system	An assembly of noninvasive devices intended to monitor the position of a patient's tumour/lesion relative to the isocenter of a radiation therapy system, to assist with their alignment during treatment planning or a therapeutic procedure. It localizes the position of invasive markers [e.g., electromagnetic (EM) signal transmitters, radiopaque markers] (not included) which have been introduced/implanted in or near the target site prior to treatment. It typically includes an EM receiver and dedicated software.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850011006047	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K152761	000

Device Sizes

Type	Value	Unit	Text
Needle Gauge	17	Gauge

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 131 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Humidity: between 20 and 80 Percent (%) Relative Humidity