| Primary Device ID | 00092237623510 |
| NIH Device Record Key | 0c0c4378-1f29-4bdc-9b43-805a6e1bc8cb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | THERADOT |
| Version Model Number | DO1009PINLW |
| Company DUNS | 827221698 |
| Company Name | COMPASS HEALTH BRANDS CORP. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| 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 | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00092237623510 [Primary] |
| IKD | Cable, Electrode |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-03 |
| Device Publish Date | 2024-05-24 |
| 91813520010242 | THERADOT APPLICATOR LEADWIRE (2/PK) |
| 00092237623510 | THERADOT PIN LEADWIRE (2/PK) |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() THERADOT 97840004 not registered Live/Pending |
Compass Health Brands Corp. 2023-03-15 |