BEUDAMED
    4 results · 26ms · Sources: EU EUDAMED, US FDA

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    Spacers of varying lengths used with the InSTANT Stranding System, Part numbers: TG3138, TG3139, TG3140, TG3141 and TG3142. Theragenics Corporation, 5203 Bristol Industrial Way, Buford GA 30518. The spacer product is intended for consumption during the brachytherapy procedure. Unused (unopened) product is not intended to be inventoried. by the attending physician.

    FDA Recall
    Terminated ·Theragenics Corporation·Product code NQO·December 8, 2008

    Theragenics Applicator Needle (18g x 20cm) The device is comprised four basic elements; a wire stylus with plastic handle, a plastic needle hub, a protective needle sleeve and the hollow steel needle.

    FDA Enforcement
    Class II ·Terminated·Theragenics Corporation·December 26, 2018

    PG910 Spacers, Part number SP101, loaded into Bard Express Seeding Cartridges containing TheraSeed Pd-103 devices. The product is shipped non-sterile in a foil pouch, packed 50 loose spacers per pouch.

    FDA Recall
    Terminated ·Theragenics Corporation·Product code KXK·May 16, 2005

    Theragenics Applicator Needle (18g x 20cm) The device is comprised four basic elements; a wire stylus with plastic handle, a plastic needle hub, a protective needle sleeve and the hollow steel needle.

    FDA Recall
    Terminated ·Theragenics Corporation·Product code IWJ·October 9, 2018