| Primary Device ID | 00191506060091 |
| NIH Device Record Key | ee7f8bf6-05ae-4231-997a-4b5bfe7af828 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OverStitch™ |
| Version Model Number | M00505410 |
| Catalog Number | M00505410 |
| Company DUNS | 021717889 |
| Company Name | BOSTON SCIENTIFIC CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00191506060091 [Primary] |
| QTD | Endoscopic suturing device for altering gastric anatomy for weight loss |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-29 |
| Device Publish Date | 2025-09-19 |
| 00191506060046 | Suture Cinch |
| 00191506060138 | Polypropylene Suture |
| 00191506060091 | Intragastric Balloon System |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() OVERSTITCH 77494566 3904728 Live/Registered |
APOLLO ENDOSURGERY US, INC. 2008-06-09 |