Primary Device ID | 08714729809425 |
NIH Device Record Key | c4564f44-c77e-47d1-ae0d-bc903b89f470 |
Commercial Distribution Discontinuation | 2021-01-19 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | Genesys HTA™ System |
Version Model Number | M006580040 |
Catalog Number | M006580040 |
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 | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
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 | 08714729809425 [Primary] |
FOX | STAND, INFUSION |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2021-05-20 |
Device Publish Date | 2018-10-15 |
00191506014643 - AGENT™ | 2024-03-29 Paclitaxel-Coated Balloon Catheter |
00191506014650 - AGENT™ | 2024-03-29 Paclitaxel-Coated Balloon Catheter |
00191506014667 - AGENT™ | 2024-03-29 Paclitaxel-Coated Balloon Catheter |
00191506014674 - AGENT™ | 2024-03-29 Paclitaxel-Coated Balloon Catheter |
00191506014681 - AGENT™ | 2024-03-29 Paclitaxel-Coated Balloon Catheter |
00191506014698 - AGENT™ | 2024-03-29 Paclitaxel-Coated Balloon Catheter |
00191506014704 - AGENT™ | 2024-03-29 Paclitaxel-Coated Balloon Catheter |
00191506014711 - AGENT™ | 2024-03-29 Paclitaxel-Coated Balloon Catheter |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
GENESYS HTA 78615028 not registered Dead/Abandoned |
Boston Scientific Scimed, Inc. 2005-04-22 |
GENESYS HTA 77896684 4084429 Live/Registered |
Boston Scientific Scimed, Inc. 2009-12-18 |