| Primary Device ID | B090SPN10051 |
| NIH Device Record Key | 7708e192-1c91-4027-a032-c84ac9c32a71 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SPINR |
| Version Model Number | SPN-1005 |
| Catalog Number | SPN-1005 |
| Company DUNS | 017535668 |
| Company Name | ZIEN MEDICAL TECHNOLOGIES, INC. |
| 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 Issuing Agency | Device ID |
|---|---|
| HIBCC | B090SPN10050 [Primary] |
| HIBCC | B090SPN10051 [Package] Contains: B090SPN10050 Package: Shelf Carton [5 Units] In Commercial Distribution |
| HIBCC | B090SPN10052 [Package] Package: Shipper [2 Units] In Commercial Distribution |
| DQX | Wire, Guide, Catheter |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-05-11 |
| Device Publish Date | 2023-05-03 |
| B0905XGW1 | Distal Access torque devices are used to maneuver guidewires in the coronary and peripheral vasc |
| B090SPN10051 | Distal Access torque devices are used to maneuver guidewires in the coronary and peripheral vasc |