ROTAPRO™ Advancer
GUDID 08714729893431
Burr Advancing Device
BOSTON SCIENTIFIC CORPORATION
Mechanical atherectomy system, coronary, line-powered| Primary Device ID | 08714729893431 |
| NIH Device Record Key | 13b1803b-5816-4879-bf00-b0844c15f34e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ROTAPRO™ Advancer |
| Version Model Number | H74939299A0 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08714729893431 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P900056
FDA Product Code
| MCX | CATHETER, CORONARY, ATHERECTOMY |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2021-04-06 |
| Device Publish Date | 2018-07-11 |
Devices Manufactured by BOSTON SCIENTIFIC CORPORATION
| 08714729838005 - Capio SLIM | 2024-11-13 Suture Capturing Device |
| 00191506043193 - FARAWAVE™ NAV | 2024-10-30 Pulsed Field Ablation Catheter |
| 00191506043209 - FARAWAVE™ NAV | 2024-10-30 Pulsed Field Ablation Catheter |
| 00191506043216 - FARAWAVE™ | 2024-10-30 Pulsed Field Ablation Catheter |
| 00191506043223 - FARAWAVE™ | 2024-10-30 Pulsed Field Ablation Catheter |
| 00191506043698 - FARASTAR™ | 2024-10-30 Pulsed Field Ablation Generator |
| 00191506043704 - FARASTAR™ | 2024-10-30 Pulsed Field Ablation Generator |
| 00191506043711 - FARASTAR™ | 2024-10-30 Pulsed Field Ablation Generator |
Trademark Results [ROTAPRO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ROTAPRO 87059328 not registered Live/Pending |
Boston Scientific Scimed, Inc. 2016-06-03 |
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