| Primary Device ID | 00802526585838 |
| NIH Device Record Key | 9e45a196-0513-4973-b224-8e35aadd95a4 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 6753 |
| 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 | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00802526585838 [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 |
| 08714729877769 - Orbiter™ ST | 2024-12-20 Bidirectional Steerable Diagnostic Catheter |
| 08714729877776 - Orbiter™ ST | 2024-12-20 Bidirectional Steerable Diagnostic Catheter |
| 08714729877783 - Orbiter™ ST | 2024-12-20 Bidirectional Steerable Diagnostic Catheter |
| 08714729877806 - Orbiter™ ST | 2024-12-20 Bidirectional Steerable Diagnostic Catheter |
| 08714729877813 - Orbiter™ ST | 2024-12-20 Bidirectional Steerable Diagnostic Catheter |
| 08714729877820 - Orbiter™ ST | 2024-12-20 Bidirectional Steerable Diagnostic Catheter |
| 08714729877837 - Orbiter™ ST | 2024-12-20 Bidirectional Steerable Diagnostic Catheter |
| 08714729877844 - Orbiter™ ST | 2024-12-20 Bidirectional Steerable Diagnostic Catheter |