BEUDAMED
    2 results · 12ms · Sources: EU EUDAMED, US FDA

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    Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure.

    FDA Enforcement
    Class II ·Ongoing·Resource Optimization & Innovation Llc·November 29, 2017

    Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial sampling is performed by compressing a spring as the base of brush wire to expose the brush, scraping the desired surface, and releasing the compression on the spring which retracts the brush back into the sheath. A protector tip on the end of the brush prevent contamination of the sample during the endoscopy procedure. The force required to dislodge the tip from the bristle is greater than to break the brush wire at the handle body.

    FDA Enforcement
    Class II ·Ongoing·Hobbs Medical, Inc.·March 9, 2022