| Primary Device ID | 08714729269779 |
| NIH Device Record Key | 9247fe72-a4af-4b1d-917c-075cb5b0e9fd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Polaris X™ |
| Version Model Number | M0045454S0 |
| Catalog Number | M0045454S0 |
| 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 | false |
| 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 | 08714729269779 [Primary] |
| DRF | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[08714729269779]
Ethylene Oxide
[08714729269779]
Ethylene Oxide
[08714729269779]
Ethylene Oxide
[08714729269779]
Ethylene Oxide
[08714729269779]
Ethylene Oxide
[08714729269779]
Ethylene Oxide
[08714729269779]
Ethylene Oxide
[08714729269779]
Ethylene Oxide
[08714729269779]
Ethylene Oxide
[08714729269779]
Ethylene Oxide
[08714729269779]
Ethylene Oxide
[08714729269779]
Ethylene Oxide
[08714729269779]
Ethylene Oxide
[08714729269779]
Ethylene Oxide
[08714729269779]
Ethylene Oxide
[08714729269779]
Ethylene Oxide
[08714729269779]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2025-02-04 |
| Device Publish Date | 2016-09-24 |
| 08714729269779 - Polaris X™ | 2025-02-04Catheter Cable, Sterile Cable |
| 08714729269779 - Polaris X™ | 2025-02-04 Catheter Cable, Sterile Cable |
| 08714729839835 - Direxion™ HI-FLO™ Transend™-18 System | 2025-01-23 Pre-Loaded Torqueable Microcatheter |
| 08714729269915 - Electrophysiology Cable | 2025-01-15 Sterile Cable |
| 08714729877868 - Radia™ | 2025-01-08 Bidirectional Steerable Diagnostic Catheter |
| 08714729877875 - Radia™ | 2025-01-08 Bidirectional Steerable Diagnostic Catheter |
| 08714729877882 - Radia™ | 2025-01-08 Bidirectional Steerable Diagnostic Catheter |
| 08714729877899 - Radia™ | 2025-01-08 Bidirectional Steerable Diagnostic Catheter |
| 08714729877905 - Radia™ | 2025-01-08 Bidirectional Steerable Diagnostic Catheter |