RotaLink™ Plus H749236310030
GUDID 08714729228363
Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
BOSTON SCIENTIFIC CORPORATION
Mechanical atherectomy system, coronary, line-powered| Primary Device ID | 08714729228363 |
| NIH Device Record Key | 85315f8f-0dba-4f09-a867-c4d1619ce22b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RotaLink™ Plus |
| Version Model Number | H749236310030 |
| Catalog Number | H749236310030 |
| 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
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08714729228363 [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 | 5 |
| Public Version Date | 2021-04-06 |
| Device Publish Date | 2014-09-24 |
On-Brand Devices [RotaLink™ Plus]
| 08714729316473 | Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device |
| 08714729316466 | Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device |
| 08714729316442 | Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device |
| 08714729316411 | Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device |
| 08714729228424 | Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device |
| 08714729228394 | Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device |
| 08714729228370 | Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device |
| 08714729228363 | Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device |
Trademark Results [RotaLink]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ROTALINK 74691391 2144951 Live/Registered |
BOSTON SCIENTIFIC SCIMED, INC. 1995-06-16 |
 ROTALINK 74691390 2144950 Live/Registered |
BOSTON SCIENTIFIC SCIMED, INC. 1995-06-16 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.