| Primary Device ID | 00802526617300 |
| NIH Device Record Key | 90e918cc-ea75-4c50-8fb0-0cee710509e2 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 6860 |
| Company DUNS | 106295384 |
| Company Name | BOSTON SCIENTIFIC CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | 00802526617300 [Primary] |
| OSR | Pacemaker/icd/crt non-implanted components |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-17 |
| Device Publish Date | 2021-06-09 |
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| 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 |
| 00802526625206 - LATITUDE™ Programming System | 2025-07-04 Programming System |
| 08714729808220 - Flextome® Cutting Balloon® | 2025-07-04 Microsurgical Dilatation Device |
| 08714729808237 - Flextome® Cutting Balloon® | 2025-07-04 Microsurgical Dilatation Device |
| 08714729808244 - Flextome® Cutting Balloon® | 2025-07-04 Microsurgical Dilatation Device |