Beacon Care Package - Soft Tissue (14G) ASM0592-000

GUDID 00850011006030

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 may only be used with the Calypso System v3.0 or higher.

VARIAN MEDICAL SYSTEMS, INC.

Implanted-marker patient positioning system Radiation therapy invasive marker lesion localization system Radiation therapy invasive marker lesion localization system Radiation therapy invasive marker lesion localization system Radiation therapy invasive marker lesion localization system Radiation therapy invasive marker lesion localization system Radiation therapy invasive marker lesion localization system Radiation therapy invasive marker lesion localization system Radiation therapy invasive marker lesion localization system Radiation therapy invasive marker lesion localization system

• Primary Device ID: 00850011006030
• NIH Device Record Key: a4b6c84e-7ba6-47fe-ba9c-76ba749ee85f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Beacon Care Package - Soft Tissue (14G)
• Version Model Number: ASM0592-000
• Catalog Number: ASM0592-000
• Company DUNS: 070809675
• Company Name: VARIAN MEDICAL SYSTEMS, 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(888)827-4265
• Email: xxx@xxx.xxx
• Phone: +1(888)827-4265
• Email: xxx@xxx.xxx
• Phone: +1(888)827-4265
• Email: xxx@xxx.xxx
• Phone: +1(888)827-4265
• Email: xxx@xxx.xxx
• Phone: +1(888)827-4265
• Email: xxx@xxx.xxx
• Phone: +1(888)827-4265
• Email: xxx@xxx.xxx
• Phone: +1(888)827-4265
• Email: xxx@xxx.xxx
• Phone: +1(888)827-4265
• Email: xxx@xxx.xxx
• Phone: +1(888)827-4265
• Email: xxx@xxx.xxx
• Phone: +1(888)827-4265
• Email: xxx@xxx.xxx

Device Dimensions

• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Humidity: between 20 and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Humidity: between 20 and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Humidity: between 20 and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Humidity: between 20 and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Humidity: between 20 and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Humidity: between 20 and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Humidity: between 20 and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Humidity: between 20 and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Humidity: between 20 and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Humidity: between 20 and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Humidity: between 20 and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850011006030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140823

FDA Product Code

• IYE: Accelerator, Linear, Medical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-21

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