ROTAPRO™ H749394671250
GUDID 08714729999560
Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
BOSTON SCIENTIFIC CORPORATION
Mechanical atherectomy system, coronary, battery-powered| Primary Device ID | 08714729999560 |
| NIH Device Record Key | 5bb9eb9a-c2e6-4f16-9805-90bce3b60757 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ROTAPRO™ |
| Version Model Number | H749394671250 |
| Catalog Number | H749394671250 |
| 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 Dimensions
| Guidewire Diameter | 1.25 Millimeter |
| Guidewire Diameter | 1.25 Millimeter |
| Guidewire Diameter | 1.25 Millimeter |
| Guidewire Diameter | 1.25 Millimeter |
| Guidewire Diameter | 1.25 Millimeter |
| Guidewire Diameter | 1.25 Millimeter |
| Guidewire Diameter | 1.25 Millimeter |
| Guidewire Diameter | 1.25 Millimeter |
| Guidewire Diameter | 1.25 Millimeter |
| Guidewire Diameter | 1.25 Millimeter |
| Guidewire Diameter | 1.25 Millimeter |
| Guidewire Diameter | 1.25 Millimeter |
| Guidewire Diameter | 1.25 Millimeter |
| Guidewire Diameter | 1.25 Millimeter |
| Guidewire Diameter | 1.25 Millimeter |
| Guidewire Diameter | 1.25 Millimeter |
| Guidewire Diameter | 1.25 Millimeter |
| Guidewire Diameter | 1.25 Millimeter |
| Guidewire Diameter | 1.25 Millimeter |
| Guidewire Diameter | 1.25 Millimeter |
| Guidewire Diameter | 1.25 Millimeter |
| Guidewire Diameter | 1.25 Millimeter |
| Guidewire Diameter | 1.25 Millimeter |
| Guidewire Diameter | 1.25 Millimeter |
| Guidewire Diameter | 1.25 Millimeter |
| Guidewire Diameter | 1.25 Millimeter |
| Guidewire Diameter | 1.25 Millimeter |
| Guidewire Diameter | 1.25 Millimeter |
| Guidewire Diameter | 1.25 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08714729999560 [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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-09 |
| Device Publish Date | 2020-07-01 |
On-Brand Devices [ROTAPRO™]
| 08714729999638 | Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device |
| 08714729999621 | Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device |
| 08714729999614 | Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device |
| 08714729999607 | Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device |
| 08714729999591 | Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device |
| 08714729999584 | Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device |
| 08714729999577 | Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device |
| 08714729999560 | Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device |
| 08714729975106 | Rotational Atherectomy System |
| 08714729975090 | Rotational Atherectomy System |
| 08714729975083 | Rotational Atherectomy System |
| 08714729975076 | Rotational Atherectomy System |
| 08714729893424 | Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device |
| 08714729893417 | Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device |
| 08714729893400 | Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device |
| 08714729893394 | Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device |
| 08714729893387 | Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device |
| 08714729893370 | Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device |
| 08714729893363 | Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device |
| 08714729893356 | Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device |
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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