Home GUDID 00817740020072 BIONIX RADIATION THERAPY
Primary DI 00817740020072
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 Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
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 Not 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 Lot or batch true 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 10817740020079 BIONIX RADIATION THERAPY BIONIX RADIATION THERAPY, LLC LGF 2017-04-25
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