Home GUDID 10855436007027 LOCalizer
Primary DI 10855436007027
Brand LOCalizer
Company HEALTH BEACONS INC
Model HB200
Device description Tag Applicator, Single
Published 2017-06-16
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety MR Conditional
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name PBY Temporary Tissue Marker
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PBY Temporary Tissue Marker General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10855436007027 Package GS1 10 Not in Commercial Distribution 00855436007020 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10855436007027 10855436007027 00855436007020 00855436007020 855436007020 0855436007020
GMDN Terms# Term, Definition table Term Definition Imaging lesion localization marker, implantable A sterile device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. It is typically formed as a wire, needle, bead, stent-like tube or washer, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 15 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 080545263 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 08719992742516 Sirius Pintuition Sirius Medical Systems B.V. PBY 2024-11-22 08719992742509 Sirius Pintuition Sirius Medical Systems B.V. PBY 2024-11-22 08719992742530 Sirius Pintuition Sirius Medical Systems B.V. PBY 2024-11-22 08719992742592 Sirius Pintuition Sirius Medical Systems B.V. PBY 2024-11-22 08719992742882 Sirius Pintuition Sirius Medical Systems B.V. PBY 2024-11-22 08719992742943 Sirius Pintuition Sirius Medical Systems B.V. PBY 2024-11-22 08719992742974 Sirius Pintuition Sirius Medical Systems B.V. PBY 2024-11-22 08719992742998 Sirius Pintuition Sirius Medical Systems B.V. PBY 2024-11-22 10855436007041 LOCalizer HEALTH BEACONS INC PBY 2018-05-03 10855436007058 LOCalizer HEALTH BEACONS INC PBY 2018-05-03 10855436007065 LOCalizer HEALTH BEACONS INC PBY 2018-05-03 00852205006017 SAVI SCOUT® CIANNA MEDICAL, INC. PBY 2017-11-22 00852205006024 SAVI SCOUT® CIANNA MEDICAL, INC. PBY 2017-11-22 00852205006031 SAVI SCOUT® CIANNA MEDICAL, INC. PBY 2017-11-22 00852205006048 SAVI SCOUT® CIANNA MEDICAL, INC. PBY 2017-11-22 00852205006093 SAVI SCOUT® CIANNA MEDICAL, INC. PBY 2017-11-22 10852205006014 SAVI SCOUT® CIANNA MEDICAL, INC. PBY 2017-11-22 00852205006055 SAVI SCOUT® CIANNA MEDICAL, INC. PBY 2017-11-22 00852205006062 SAVI SCOUT® CIANNA MEDICAL, INC. PBY 2017-11-22 00852205006079 SAVI SCOUT® CIANNA MEDICAL, INC. PBY 2017-11-22 00852205006086 SAVI SCOUT® CIANNA MEDICAL, INC. PBY 2017-11-22 10852205006090 SAVI SCOUT® CIANNA MEDICAL, INC. PBY 2017-11-22 00855436007013 LOCalizer HEALTH BEACONS, INC. PBY 2017-06-16 00855436007020 LOCalizer HEALTH BEACONS, INC. PBY 2017-06-16 10855436007010 LOCalizer HEALTH BEACONS INC PBY 2017-06-16 00855436007037 LOCalizer HEALTH BEACONS, INC. PBY 2017-06-16