| Primary Device ID | 10607567107943 |
| NIH Device Record Key | 4eb37324-da08-4a8a-a66c-0df140588e0c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Reinforced Introducer Set for Sensation Plus & Mega 8Fr |
| Version Model Number | 0684-00-0403-10 |
| Catalog Number | 0684-00-0403-10 |
| Company DUNS | 001660786 |
| Company Name | DATASCOPE CORP. |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10607567107943 [Primary] |
| DYB | Introducer, Catheter |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10607567107943]
Ethylene Oxide
[10607567107943]
Ethylene Oxide
[10607567107943]
Ethylene Oxide
[10607567107943]
Ethylene Oxide
[10607567107943]
Ethylene Oxide
[10607567107943]
Ethylene Oxide
[10607567107943]
Ethylene Oxide
[10607567107943]
Ethylene Oxide
[10607567107943]
Ethylene Oxide
[10607567107943]
Ethylene Oxide
[10607567107943]
Ethylene Oxide
[10607567107943]
Ethylene Oxide
[10607567107943]
Ethylene Oxide
[10607567107943]
Ethylene Oxide
[10607567107943]
Ethylene Oxide
[10607567107943]
Ethylene Oxide
[10607567107943]
Ethylene Oxide
[10607567107943]
Ethylene Oxide
[10607567107943]
Ethylene Oxide
[10607567107943]
Ethylene Oxide
[10607567107943]
Ethylene Oxide
[10607567107943]
Ethylene Oxide
[10607567107943]
Ethylene Oxide
[10607567107943]
Ethylene Oxide
[10607567107943]
Ethylene Oxide
[10607567107943]
Ethylene Oxide
[10607567107943]
Ethylene Oxide
[10607567107943]
Ethylene Oxide
[10607567107943]
Ethylene Oxide
[10607567107943]
Ethylene Oxide
[10607567107943]
Ethylene Oxide
[10607567107943]
Ethylene Oxide
[10607567107943]
Ethylene Oxide
[10607567107943]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-22 |
| Device Publish Date | 2023-03-14 |
| 10607567113432 - CARDIOSAVE HYBRID, 3.1 EDITION | 2024-09-17 CARDIOSAVE HYBRID, 3.1 EDITION |
| 10607567113449 - CARDIOSAVE RESCUE, 3.1 EDITION | 2024-09-17 CARDIOSAVE RESCUE, 3.1 EDITION |
| 10607567114187 - CARDIOSAVE HYBRID - TYPE "N" PLUG | 2024-09-17 CARDIOSAVE HYBRID - TYPE "N" PLUG |
| 10607567107585 - YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT | 2024-08-20 YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT |
| 10607567107592 - YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT (APA) | 2024-08-20 YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT (APA) |
| 10607567107608 - YAMATO PLUS-R 35cc IAB WITH ACCESSORIES AND RETRACTION KIT | 2024-08-20 YAMATO PLUS-R 35cc IAB WITH ACCESSORIES AND RETRACTION KIT |
| 10607567107639 - YAMATO PLUS-R 40cc IAB WITH ACCESSORIES AND RETRACTION KIT (APA) | 2024-08-20 YAMATO PLUS-R 40cc IAB WITH ACCESSORIES AND RETRACTION KIT (APA) |
| 10607567111537 - Catheter Extender for Yamato Plus IABs - 10 Pack | 2024-08-20 Catheter Extender for Yamato Plus IABs - 10 Pack |