| Primary Device ID | 10607567114217 |
| NIH Device Record Key | 04cd3edc-5467-4745-a8bc-95271c629c12 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Insertion Kit with 6” (15cm) Introducer for use with MEGA 8Fr. 50cc IAB |
| Version Model Number | 0884-00-0019-17U |
| Catalog Number | 0884-00-0019-17U |
| 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 | 10607567114217 [Primary] |
| DSP | System, Balloon, Intra-Aortic And Control |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10607567114217]
Ethylene Oxide
[10607567114217]
Ethylene Oxide
[10607567114217]
Ethylene Oxide
[10607567114217]
Ethylene Oxide
[10607567114217]
Ethylene Oxide
[10607567114217]
Ethylene Oxide
[10607567114217]
Ethylene Oxide
[10607567114217]
Ethylene Oxide
[10607567114217]
Ethylene Oxide
[10607567114217]
Ethylene Oxide
[10607567114217]
Ethylene Oxide
[10607567114217]
Ethylene Oxide
[10607567114217]
Ethylene Oxide
[10607567114217]
Ethylene Oxide
[10607567114217]
Ethylene Oxide
[10607567114217]
Ethylene Oxide
[10607567114217]
Ethylene Oxide
[10607567114217]
Ethylene Oxide
[10607567114217]
Ethylene Oxide
[10607567114217]
Ethylene Oxide
[10607567114217]
Ethylene Oxide
[10607567114217]
Ethylene Oxide
[10607567114217]
Ethylene Oxide
[10607567114217]
Ethylene Oxide
[10607567114217]
Ethylene Oxide
[10607567114217]
Ethylene Oxide
[10607567114217]
Ethylene Oxide
[10607567114217]
Ethylene Oxide
[10607567114217]
Ethylene Oxide
[10607567114217]
Ethylene Oxide
[10607567114217]
Ethylene Oxide
[10607567114217]
Ethylene Oxide
[10607567114217]
Ethylene Oxide
[10607567114217]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-02-28 |
| Device Publish Date | 2024-02-20 |
| 10607567107493 | Insertion Kit with 6” (15cm) Introducer for use with MEGA 8Fr. 50cc IAB |
| 10607567114217 | Insertion Kit with 6” (15cm) Introducer for use with MEGA 8Fr. 50cc IAB |