ReShape™ Integrated Dual Balloon System RSM101
GUDID B001RSM1011
IMPLANT, INTRAGASTRIC BALLOON FOR OBESITY
RESHAPE MEDICAL, INC.
Appetite-suppression gastric balloon| Primary Device ID | B001RSM1011 |
| NIH Device Record Key | aedf4335-a29c-4c80-a7f0-1597ffae9327 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ReShape™ Integrated Dual Balloon System |
| Version Model Number | RSM101 |
| Catalog Number | RSM101 |
| Company DUNS | 877283486 |
| Company Name | RESHAPE MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B001RSM1011 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P140012
FDA Product Code
| LTI | Implant, Intragastric For Morbid Obesity |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-08-25 |
Devices Manufactured by RESHAPE MEDICAL, INC.
| B001RSM1011 - ReShape™ Integrated Dual Balloon System | 2018-07-06IMPLANT, INTRAGASTRIC BALLOON FOR OBESITY |
| B001RSM1011 - ReShape™ Integrated Dual Balloon System | 2018-07-06 IMPLANT, INTRAGASTRIC BALLOON FOR OBESITY |
| B001RSM1101 - ReShape® Integrated Dual Balloon System | 2018-07-06 IMPLANT, INTRAGASTRIC BALLOON FOR OBESITY |
| B001RSM2101 - ReShape™ Removal Catheter | 2018-07-06 ReShape™ Removal Catheter - component to remove the ReShape™ Integrated Dual Balloon |
| B001RSM9001 - ReShape™ Valve Sealant | 2018-07-06 ReShape™ Valve Sealant - component for use with the ReShape™ Integrated Dual Balloon |
Trademark Results [ReShape]
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