| Primary Device ID | 00802526585807 |
| NIH Device Record Key | 877503cf-932d-4281-b654-72678f25d89a |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 6175 |
| Company DUNS | 106295384 |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 | 00802526585807 [Primary] |
| OSR | Pacemaker/icd/crt non-implanted components |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-11-20 |
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| 00191506055769 - IceSphere™ | 2025-02-27 Cryoablation Needle |
| 00191506055776 - IceRod™ | 2025-02-27 Cryoablation Needle |
| 00191506060138 - OverStitch™ | 2025-02-25 Polypropylene Suture |
| 00191506049157 - X-Tack™ | 2025-02-25 Endoscopic HeliX Tacking System (Gastric) |
| 00191506049164 - X-Tack™ | 2025-02-25 Endoscopic HeliX Tacking System (Colonic) |
| 00191506049188 - NA | 2025-02-25 Suture Cinch - Long |
| 00191506060046 - OverStitch™ | 2025-02-25 Suture Cinch |