| Primary Device ID | 00802526077494 |
| NIH Device Record Key | a92e1476-9fb6-44ea-ab54-2e1b0f185281 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 6577 |
| 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 | 00802526077494 [Primary] |
| LWS | Implantable cardioverter defibrillator (non-CRT) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-07-30 |
| Device Publish Date | 2014-09-24 |
| 00802526618208 - myLUX™ Patient App | 2025-04-21 For Insertable Cardiac Monitor |
| 00802526618215 - myLUX™ Patient App | 2025-04-21 for Insertable Cardiac Monitor |
| 00191506046330 - Sterling™ | 2025-03-31 PTA Balloon Dilatation Catheter |
| 00191506046347 - Sterling™ | 2025-03-31 PTA Balloon Dilatation Catheter |
| 00191506046354 - Sterling™ | 2025-03-31 PTA Balloon Dilatation Catheter |
| 00191506046361 - Sterling™ | 2025-03-31 PTA Balloon Dilatation Catheter |
| 00191506046378 - Sterling™ | 2025-03-31 PTA Balloon Dilatation Catheter |
| 00191506046385 - Sterling™ | 2025-03-31 PTA Balloon Dilatation Catheter |