Duns Number:070809675
Device Description: The Beacon transponder is an implantable wireless device composed of an internal circuit a 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.
Catalog Number
ASM0607-001
Brand Name
Beacon Care Package - Soft Tissue (17G)
Version/Model Number
ASM0607-001
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K152761
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
6e7abbc8-b066-44cc-84ef-2ed9f09d6847
Public Version Date
August 24, 2021
Public Version Number
4
DI Record Publish Date
January 21, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 253 |