| Primary Device ID | 03665134000714 |
| NIH Device Record Key | 1e2c0ba0-bafa-4a3e-9083-aba96578ca63 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PROMAP – 3D PROSTATE SUITE |
| Version Model Number | KSOF-2602 |
| Company DUNS | 290318455 |
| Company Name | KOELIS |
| 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 | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 |
|---|---|
| GS1 | 03665134000714 [Primary] |
| LLZ | System, Image Processing, Radiological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-29 |
| Device Publish Date | 2022-07-21 |
| 03665134000851 - 3D Side Fire Endocavity Probe | 2024-08-07 |
| 03665134000936 - Steady Pro | 2024-06-11 Probe holder for transperineal approach. The Steady Pro range is intended to reliably maintain the position of a transrectal ult |
| 03665134000929 - MrDraw | 2023-10-10 A system based on the PROMAP – 3D Prostate Suite range intended to define prostate contour and targets the region of interest |
| 03665134000509 - 3D End-Fire Endocavity Probe | 2023-04-13 Invasive 2D/3D endocavity probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam, 3 |
| 03665134000516 - 3D Side-Fire Endocavity Probe | 2023-04-13 Invasive 2D/3D endocavity probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam, 3 |
| 03665134000523 - 2D Abdominal Probe | 2023-04-13 Surface 2D probe (Convex) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam for Abdominal, Gy |
| 03665134000530 - 2D Linear Probe | 2023-04-13 Surface 2D probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam for Abdominal, Gy |
| 03665134000189 - CON LEAD 14G | 2023-04-13 Needle guide compatible with the abdominal 2D ultrasound probe. It is made of two parts. One part is fixed on the ultrasound pro |