Home GUDID 10817740020079 BIONIX RADIATION THERAPY
Primary DI 10817740020079
Brand BIONIX RADIATION THERAPY
Company BIONIX RADIATION THERAPY, LLC
Model EMRT-8300
Catalog number EMRT-8300
Device description 2.4MM 10X10, STANDARD U-FRAME
Published 2017-04-25
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name LGF Component, cast
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LGF Component, Cast Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10817740020079 Package GS1 10 In Commercial Distribution 00817740020072 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 10817740020079 10817740020079 00817740020072 00817740020072 817740020072 0817740020072
GMDN Terms# Term, Definition table Term Definition Spine thermoplastic splint system An assembly of non-sterile devices designed to produce a thermoformable splint intended to be applied externally to the spine of a patient who requires support or immobilization (e.g., to treat fractures, injuries, sprains). It typically consists of a low-temperature thermoplastic material and a textile (e.g., cotton) in the form of the spine and into which the thermoplastic is inserted; the combination is warmed in a water bath for adaptability to the shape of the patient?s spine. It is available in various dimensions and may be used in various clinical specialties. This is a single-patient device that may be reapplied over a short term (single-use) before being discarded.
Regulatory Flags# DUNS number 080397923 Device count 1 DM exempt true Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false 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 G064208317270091511 CastWedge™ POSITION HEALTH, LLC LGF 2022-12-09 G064208317270092051 CastWedge™ POSITION HEALTH, LLC LGF 2022-12-09 G064208317270092501 CastWedge™ POSITION HEALTH, LLC LGF 2022-12-09 G064208317270093041 CastWedge™ POSITION HEALTH, LLC LGF 2022-12-09 G064208317270091061 CastWedge™ POSITION HEALTH, LLC LGF 2022-12-09 00632195000659 Tex-Care Medical Flynt/Amtex, Inc. LGF 2021-12-15 00632195001694 Tex-Care Medical Flynt/Amtex, Inc. LGF 2021-12-15 00632195002462 Tex-Care Medical Flynt/Amtex, Inc. LGF 2021-12-15 00632195002479 Tex-Care Medical Flynt/Amtex, Inc. LGF 2021-12-15 00632195002486 Tex-Care Medical Flynt/Amtex, Inc. LGF 2021-12-15 00632195002493 Tex-Care Medical Flynt/Amtex, Inc. LGF 2021-12-15 00632195002509 Tex-Care Medical Flynt/Amtex, Inc. LGF 2021-12-15 00632195002516 Tex-Care Medical Flynt/Amtex, Inc. LGF 2021-12-15 00632195000505 Tex-Care Medical Flynt/Amtex, Inc. LGF 2021-10-29 00632195000529 Tex-Care Medical Flynt/Amtex, Inc. LGF 2021-10-29 00632195000543 Tex-Care Medical Flynt/Amtex, Inc. LGF 2021-10-29 00632195000567 Tex-Care Medical Flynt/Amtex, Inc. LGF 2021-10-29 00632195000581 Tex-Care Medical Flynt/Amtex, Inc. LGF 2021-10-29 00632195000604 Tex-Care Medical Flynt/Amtex, Inc. LGF 2021-10-29 00632195000628 Tex-Care Medical Flynt/Amtex, Inc. LGF 2021-10-29 00632195000642 Tex-Care Medical Flynt/Amtex, Inc. LGF 2021-10-29 00817740020072 BIONIX RADIATION THERAPY Bionix Radiation Therapy, LLC LGF 2017-04-25
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