Duns Number:078473721
Device Description: Beacon Tissue Marker/Beacon Tissue Marker (SE) is a sterile, single patient use, PEKK disc Beacon Tissue Marker/Beacon Tissue Marker (SE) is a sterile, single patient use, PEKK discrete marker that is visible on standard radiographs (x-ray, mammography) aswell as ultrasound, and Magnetic Resonance Imaging (MRI) at up to 3.0 Tesla field strength. Beacon Tissue Marker/Beacon Tissue Marker (SE) is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location. Beacon Tissue Marker/Beacon Tissue Marker (SE) is supplied pre-loaded in the delivery device. The Beacon Tissue Marker delivery device has a beveled 12cm/14G needle with 1cm depth marks and a plunger. The Beacon Tissue Marker (SE) delivery device has a radiused tip 12cm/14G cannula with 1cm depth marks anda plunger.
Catalog Number
-
Brand Name
BEACON
Version/Model Number
BM1412-50-1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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"
Yes
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
-
Product Code
NEU
Product Code Name
Marker, Radiographic, Implantable
Public Device Record Key
6c1d53fb-b045-4ab0-b8d4-4c4e17f36055
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
September 30, 2016
Package DI Number
10866479000104
Quantity per Package
10
Contains DI Package
00866479000107
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |