Beacon Care Package - Soft Tissue (17G)

GUDID 00850011006139

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.

VARIAN MEDICAL SYSTEMS, INC.

Radiation therapy invasive marker lesion localization system
Primary Device ID00850011006139
NIH Device Record Key2f97db69-9bf1-4ef1-bff2-71cb26f94f99
Commercial Distribution StatusIn Commercial Distribution
Brand NameBeacon Care Package - Soft Tissue (17G)
Version Model NumberASM0607-002
Company DUNS009120817
Company NameVARIAN MEDICAL SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

Needle Gauge17 Gauge
Needle Gauge17 Gauge
Needle Gauge17 Gauge
Needle Gauge17 Gauge
Needle Gauge17 Gauge
Needle Gauge17 Gauge
Needle Gauge17 Gauge
Needle Gauge17 Gauge
Needle Gauge17 Gauge
Needle Gauge17 Gauge
Needle Gauge17 Gauge

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100850011006139 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, linear, medical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-09
Device Publish Date2022-08-01

On-Brand Devices [Beacon Care Package - Soft Tissue (17G)]

00850011006047The Beacon transponder is an implantable wireless device composed of an internal circuit and enc
00850011006139The Beacon transponder is an implantable wireless device composed of an internal circuit and enc

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