Reshape Medical Inc

2 devices in the database

  • Model / Serial
    Lot Number Expiration Date 160815-001 2018-08-07 160816-001 2018-08-07 160824-003 2018-08-18 160825-001 2018-08-18 160825-002 2018-08-18
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution in the states of: MO, TX, AZ, CA, NY, TN, GA, LA, FL, MA, OH, IN, IL
  • Product Description
    ReShape Integrated Dual Balloon System, Gen 1, Model No. 01-0013-001, Catalog No. RSM110 || product Usage: || The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet and exercise, in obese patients with a Body Mass Index (BMI) of 30 40 kg/m2 and one or more obesityrelated comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone.
  • Model / Serial
    160317-001, 160371-002, 160317-003, 160324-010.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    US: Distribution to the states of : NY, OH and CA.
  • Product Description
    ReShape Integrated Dual Balloon System, Gen 1, Catalog No. RSM110, Model No. 01-0013-001 || The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet and exercise, in obese patients with a Body Mass Index (BMI) of 30 40 kg/m2 and one or more obesity related comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone.