| Primary Device ID | 08714729784432 |
| NIH Device Record Key | 9065eacf-eeda-4bf0-a2d9-41fbccaad211 |
| Commercial Distribution Discontinuation | 2024-02-21 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Percutaneous Tract Kit |
| Version Model Number | M0064501140 |
| Company DUNS | 021717889 |
| Company Name | BOSTON SCIENTIFIC CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08714729784432 [Primary] |
| OFC | Catheter introducer kit |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-10-11 |
| Device Publish Date | 2017-09-24 |
| 08714729877769 - Orbiter™ ST | 2024-12-20 Bidirectional Steerable Diagnostic Catheter |
| 08714729877776 - Orbiter™ ST | 2024-12-20 Bidirectional Steerable Diagnostic Catheter |
| 08714729877783 - Orbiter™ ST | 2024-12-20 Bidirectional Steerable Diagnostic Catheter |
| 08714729877806 - Orbiter™ ST | 2024-12-20 Bidirectional Steerable Diagnostic Catheter |
| 08714729877813 - Orbiter™ ST | 2024-12-20 Bidirectional Steerable Diagnostic Catheter |
| 08714729877820 - Orbiter™ ST | 2024-12-20 Bidirectional Steerable Diagnostic Catheter |
| 08714729877837 - Orbiter™ ST | 2024-12-20 Bidirectional Steerable Diagnostic Catheter |
| 08714729877844 - Orbiter™ ST | 2024-12-20 Bidirectional Steerable Diagnostic Catheter |