| Primary Device ID | 08714729045076 |
| NIH Device Record Key | 18fdea74-9c7c-4390-b403-c4aadee776f1 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | M0067201010 |
| 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 | 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 | 08714729045076 [Package] Contains: 08714729752998 Package: [5 Units] In Commercial Distribution |
| GS1 | 08714729752998 [Primary] |
| FFY | Adaptor, bulbs, miscellaneous, for endoscope |
| KQT | EVACUATOR, GASTRO-UROLOGY |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2022-06-10 |
| Device Publish Date | 2016-09-24 |
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| 00191506047207 - FARAPOINT™ | 2026-01-28 Pulsed Field Ablation Catheter |
| 00191506047221 - FARAPOINT™ | 2026-01-28 Pulsed Field Ablation Catheter |
| 00191506055073 - FARASTAR™ | 2026-01-28 Inter-Connection Box |
| 00191506057688 - FARASTAR™ | 2026-01-28 Pulsed Field Ablation Generator |
| 08714729780489 - Blazer™ Dx-20 | 2026-01-21 Bidirectional Steerable Diagnostic Catheter |
| 08714729780496 - Blazer™ Dx-20 | 2026-01-21 Bidirectional Steerable Diagnostic Catheter |