| Primary Device ID | 00191506060060 |
| NIH Device Record Key | 816e35c4-b0ab-4d1a-a604-261c0b582db3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NXT Tissue HeliX Pro |
| Version Model Number | M00505490 |
| Catalog Number | M00505490 |
| 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 | 00191506060060 [Primary] |
| OCW | Endoscopic tissue approximation device |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-05 |
| Device Publish Date | 2025-07-28 |
| 00191506049379 - OverTube™ | 2025-08-05 Endoscopic Access System |
| 00191506060053 - Tissue Helix | 2025-08-05 Tissue HeliX Pro |
| 00191506060060 - NXT Tissue HeliX Pro | 2025-08-05Intragastric Balloon System |
| 00191506060060 - NXT Tissue HeliX Pro | 2025-08-05 Intragastric Balloon System |
| 00191506060107 - OverStitch NXT ™ | 2025-08-05 Intragastric Balloon System |
| 08714729144182 - Optiflo | 2025-07-17 Hemostasis Catheter |
| 08714729145264 - Optiflo | 2025-07-17 Hemostasis Catheter |
| 08714729874805 - LithoVue | 2025-07-08 Single-Use Digital Flexible Ureteroscope |
| 08714729874812 - LithoVue | 2025-07-08 Single-Use Digital Flexible Ureteroscope |