Identity
- Trade Name
- Beacon Care Package - Prostate FDA UDI
- Generic Name
- Radiation therapy invasive marker lesion localization system FDA UDI
- Device Name
- 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 determine the location of the transponder, by the Calypso System. FDA UDI
- Model / Reference
- ASM0094-003 FDA UDI
- 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 determine the location of the transponder, by the Calypso System. FDA UDI
Identifiers
- Catalog Number
- ASM0094-003 FDA UDI
- Primary DI / UDI-DI
- 00850011006009 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Radiation therapy invasive marker lesion localization system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 14 Gauge FDA UDI
Category: Radiation therapy invasive marker lesion localization system
Beacon Care Package - Prostate by Varian Medical Systems, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc
Sources (1)
- FDA UDI 93f68e94-e05e-4229-81e8-e5c7d9178c32 37 fields · synced May 30, 2026