Beacon

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…

Registry build 21.09.26

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.

1manufacturer
2catalogue numbers in this listing

Who Else Makes It

Registered in Shanghai.

Chinese manufacturers registered for FDA product code NEU
Manufacturer City Province Registered as Device types
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106

Record

Regulatory record for Beacon
Listed by Scion Medical Techologies, LLC
FDA product code NEU
Device type Marker, Radiographic, Implantable
Device class Class 2
Regulation 21 CFR 878.4300
Record published 2016-09-30
Record revised 2023-09-18 (version 6)

Specifications

Specifications
MRI safety MR Unsafe
Supplied sterile Yes
Single use Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Packaging Pack of 10

Catalogue Numbers

Catalogue numbers for Beacon
Catalogue number Size Status
BM1412-50-F-1 In distribution
BM1412-50-1 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
HydroMARK Devicor Medical Products, Inc. 75
Scout® Merit Medical Systems, Inc. 68
Scout MD™ Merit Medical Systems, Inc. 46
SmartClip Elucent Medical Inc. 37
BiomarC® Carbon Medical Technologies, Inc. 25
HydroMARK Breast Biopsy Site Marker Devicor Medical Products, Inc. 21
SecurMark Hologic, Inc. 15
Gold Marker Riverpoint Medical LLC 15
MammoStar™ Carbon Medical Technologies, Inc. 15
SecurMark for Atec Hologic, Inc. 15
SenoMark® Ultra Breast Tissue Marker Bard Peripheral Vascular, Inc. 14
TriMark Hologic, Inc. 14

Showing 12 of 96. All products under Marker, Radiographic, Implantable

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer