| Primary Device ID | 07290017811000 |
| NIH Device Record Key | 03fdc336-461d-432c-b1b2-b6e6edd6471c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TSP Crosser Transseptal Access System |
| Version Model Number | TSUS001 |
| Company DUNS | 532245789 |
| Company Name | TRANSSEPTAL SOLUTIONS LTD |
| 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 | true |
| 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 |
| Phone | 774-827-2173 |
| tsphelp@bbacro.com |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark and dry place |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290017811000 [Primary] |
| GS1 | 07290017811017 [Package] Package: Unit box [1 Units] In Commercial Distribution |
| GS1 | 17290017811007 [Package] Package: Shipment Box [1 Units] In Commercial Distribution |
| GS1 | 17290017811014 [Package] Package: Shipment box 1 Pack [1 Units] In Commercial Distribution |
| GS1 | 27290017811011 [Package] Package: Shipment box 2 Pack [2 Units] In Commercial Distribution |
| GS1 | 37290017811018 [Package] Package: Shipment box 3 pack [3 Units] In Commercial Distribution |
| GS1 | 47290017811015 [Package] Package: Shipment box 4 pack [4 Units] In Commercial Distribution |
| GS1 | 57290017811005 [Package] Package: Shipment [5 Units] In Commercial Distribution |
| GS1 | 57290017811012 [Package] Package: Shipment box 5 pack [5 Units] In Commercial Distribution |
| DYB | Introducer, Catheter |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-05-02 |
| Device Publish Date | 2019-04-19 |
| 07290017811000 | The TSP Crosser System is intended to be used both to puncture the interatrial septum during a t |
| 07290017811017 | The TSP Crosser System is intended to be used both to puncture the interatrial septum during a t |