| Primary Device ID | 08720648846052 |
| NIH Device Record Key | c7c07107-ab2e-4d99-a7b3-f6f3575c25c2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SOLAR Compact |
| Version Model Number | G4-1 |
| Company DUNS | 117783313 |
| Company Name | Laborie Medical Technologies Corp. |
| 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 | true |
| Manufacturing Date | true |
| 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 | 08720648846052 [Primary] |
| FFX | System, Gastrointestinal Motility (Electrical) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-14 |
| Device Publish Date | 2025-03-06 |
| 00627825014823 - SOLAR Anorectal Manometry Charger | 2025-03-14 SOLAR Anorectal Manometry Charger |
| 10627825014837 - SOLAR Anorectal Manometry Catheter | 2025-03-14 SOLAR Anorectal Manometry Catheter |
| 08720648846052 - SOLAR Compact | 2025-03-14SOLAR Compact |
| 08720648846052 - SOLAR Compact | 2025-03-14 SOLAR Compact |
| 08720648846069 - PIM NXT for eSense | 2025-03-03 |
| 00627825013529 - e•Sense 7Fr Single Sensor Bladder Catheter | 2024-12-20 e•Sense 7Fr Single Sensor Bladder Catheter |
| 10627825013533 - e•Sense 7Fr Single Sensor Coudé Bladder Catheter | 2024-12-20 e•Sense 7Fr Single Sensor Coudé Bladder Catheter |
| 10627825013540 - e•Sense 7Fr Dual Sensor Urethral Catheter | 2024-12-20 e•Sense 7Fr Dual Sensor Urethral Catheter |
| 00627825013550 - e•Sense 7Fr Dual Sensor Coudé Uretheral Catheter | 2024-12-20 e•Sense 7Fr Dual Sensor Coudé Uretheral Catheter |