| Primary Device ID | 03760124132199 |
| NIH Device Record Key | 2631fe8e-4b0a-4c76-a1dd-2e783a7372b0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Polaris valves electronic reading instrument |
| Version Model Number | PAK3-ERI |
| Company DUNS | 262951353 |
| Company Name | SOPHYSA |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03760124132199 [Primary] |
| JXG | Shunt, Central Nervous System And Components |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-04-13 |
| Device Publish Date | 2023-04-05 |
| 03760124132908 - Sophysa | 2024-04-03 PRESSIO ICP & ICT MONITORING KIT, PARENCHYMAL W/BOLT |
| 03760124132915 - Sophysa | 2024-04-03 PRESSIO ICP & ICT MONITORING KIT, PARENCHYMAL TUNNELING |
| 03760124132922 - Sophysa | 2024-04-03 PRESSIO ICP & ICT MONITORING KIT, VENTRICULAR TUNNELING |
| 03760124133813 - Phoenix Neuro | 2024-02-05 Disposable catheter passer with sheath, 30 cm length |
| 03760124134803 - Phoenix Neuro | 2024-02-05 Disposable catheter passer with sheath, 45 cm length |
| 03760124134810 - Phoenix Neuro | 2024-02-05 Disposable catheter passer with sheath, 65 cm length |
| 03760124131444 - Sophysa | 2023-06-12 DISPOSABLE TUBUAR SHEATH FOR CATHETER PASSER 45 CM |
| 13760124131458 - Sophysa | 2023-06-12 DISPOSABLE TUBUAR SHEATH FOR CATHETER PASSER 65 CM |