| Primary Device ID | 00802526623400 |
| NIH Device Record Key | fa5845be-8848-481c-8fd8-6eb1f2de0e98 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 6946 |
| Catalog Number | 6946 |
| 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 | true |
| 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 | 00802526623400 [Primary] |
| LWS | Implantable cardioverter defibrillator (non-CRT) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-06 |
| Device Publish Date | 2024-08-29 |
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| 08714729991083 - Direxion™ Fathom™-16 System | 2024-09-25 Pre-Loaded Torqueable Microcatheter |
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