| Primary Device ID | 00802526610615 |
| NIH Device Record Key | c3733906-0265-4d31-bfe7-3b628df26fd5 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 6395 |
| Company DUNS | 106295384 |
| Company Name | BOSTON SCIENTIFIC CORPORATION |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Serial Number | true |
| 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 | 00802526610615 [Primary] |
| OSR | Pacemaker/icd/crt non-implanted components |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00802526610615]
Ethylene Oxide
[00802526610615]
Ethylene Oxide
[00802526610615]
Ethylene Oxide
[00802526610615]
Ethylene Oxide
[00802526610615]
Ethylene Oxide
[00802526610615]
Ethylene Oxide
[00802526610615]
Ethylene Oxide
[00802526610615]
Ethylene Oxide
[00802526610615]
Ethylene Oxide
[00802526610615]
Ethylene Oxide
[00802526610615]
Ethylene Oxide
[00802526610615]
Ethylene Oxide
[00802526610615]
Ethylene Oxide
[00802526610615]
Ethylene Oxide
[00802526610615]
Ethylene Oxide
[00802526610615]
Ethylene Oxide
[00802526610615]
Ethylene Oxide
[00802526610615]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-13 |
| Device Publish Date | 2020-05-05 |
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| 00802526618215 - myLUX™ Patient App | 2025-04-21 for Insertable Cardiac Monitor |
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| 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 |