Manufacturers

Reshape Medical Inc

2 devices in the database

ReShape
  • 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
    Gastroenterology-Urology Devices
  • 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.
Device Recall ReShape Integrated Dual Balloon System, Gen 1
  • Model / Serial
    160317-001, 160371-002, 160317-003, 160324-010.
  • Product Classification
    Gastroenterology-Urology Devices
  • 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.