| 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 |
| 08714729838005 - Capio SLIM | 2024-11-13 Suture Capturing Device |
| 00191506043193 - FARAWAVE™ NAV | 2024-10-30 Pulsed Field Ablation Catheter |
| 00191506043209 - FARAWAVE™ NAV | 2024-10-30 Pulsed Field Ablation Catheter |
| 00191506043216 - FARAWAVE™ | 2024-10-30 Pulsed Field Ablation Catheter |
| 00191506043223 - FARAWAVE™ | 2024-10-30 Pulsed Field Ablation Catheter |
| 00191506043698 - FARASTAR™ | 2024-10-30 Pulsed Field Ablation Generator |
| 00191506043704 - FARASTAR™ | 2024-10-30 Pulsed Field Ablation Generator |
| 00191506043711 - FARASTAR™ | 2024-10-30 Pulsed Field Ablation Generator |