Breg Inc

12 devices in the database

  • Model / Serial
    Lot No. 705593
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA Nationwide Worldwide in the states of: TX, KY, IN, and FL.
  • Product Description
    K-Lite Knee 2 Stays with Visco, Model No. 122015. || Product Usage: || The product is intended to provide flexible knee support.
  • Model / Serial
    Lot No. 705764
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA Nationwide Worldwide in the states of: TX, KY, IN, and FL.
  • Product Description
    Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415. || Product Usage: The product is intended to provide flexible knee support.
  • Model / Serial
    Affected product will be identified by date of manufacture from January 2010 through October 2012
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Australia, Singapore, Chile, Latvia.
  • Product Description
    BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 02510, 09901, 02330, 02350, 02490, 02356, 02496, 02410, 02430. Local anesthetic effect.
  • Model / Serial
    Affected product will be identified by date of manufacture from January 2010 through October 2012.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Australia, Singapore, Chile, Latvia.
  • Product Description
    BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 10903, 10703, 09101, 09111, 09131, 09731, 09611, 09621, and 09631. Local anesthetic effect.
  • Model / Serial
    D163444
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    If Hip, Sterile Polar Dressing P/N 10680 || Product Usage: || These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them.
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3 manufacturers with a similar name

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