| Primary Device ID | B090PWR101 |
| NIH Device Record Key | 4f2449e2-f213-46eb-8355-97355ad268f6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PowrSyringe |
| Version Model Number | PWR-10 |
| 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 | B090PWR100 [Primary] |
| HIBCC | B090PWR101 [Package] Contains: B090PWR100 Package: Shelf Carton [1 Units] In Commercial Distribution |
| HIBCC | B090PWR102 [Package] Package: Shipper [10 Units] In Commercial Distribution |
| FMF | Syringe, Piston |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-31 |
| Device Publish Date | 2022-08-23 |
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| B0902P0130S1 - Knight Microcatheter | 2024-05-08 The Knight microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective inf |
| B090E20130B1 - XO Cath | 2024-05-08 The XO Cath microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective in |
| B090E20130S1 - XO Cath | 2024-05-08 The XO Cath microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective in |
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| B090LRN0591 - LANDMARK | 2024-01-31 The LANDMARK REBOA catheter is intended for temporary occlusion of large vessels including patients requiring emergency control |
| B090ASP10131 - Control 7F Mechanical Thrombectomy System | 2023-05-11 The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft em |
| B090ASP10211 - Control 11F Mechanical Thrombectomy System | 2023-05-11 The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft em |