| Primary Device ID | 00815290015623 |
| NIH Device Record Key | c0eada14-3937-4c63-b197-8b439ba48794 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Therapist’s Choice® |
| Version Model Number | TC120R |
| Catalog Number | TC120R |
| Company DUNS | 004416769 |
| Company Name | CLINICAL HEALTH SERVICES, 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 | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | true |
| Phone | 813-871-3120 |
| jeff@clinicalhealthservices.com | |
| Phone | 813-871-3120 |
| jeff@clinicalhealthservices.com | |
| Phone | 813-871-3120 |
| jeff@clinicalhealthservices.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815290015593 [Primary] |
| GS1 | 00815290015609 [Package] Contains: 00815290015593 Package: poly bag [10 Units] In Commercial Distribution |
| GS1 | 00815290015616 [Package] Contains: 00815290015609 Package: inner box [10 Units] In Commercial Distribution |
| GS1 | 00815290015623 [Package] Contains: 00815290015616 Package: master case [5 Units] In Commercial Distribution |
| GXY | Electrode, Cutaneous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-04-19 |
| 00815290015623 | TC120R- 2" Round" electrodes, white cloth, carbon, plastic zip lock |
| 00815290015586 | WF120- 2"x2" electrodes, white Foam, carbon, plastic zip lock |
| 00815290014947 | TC120- 2"x2" electrodes, white cloth, carbon, plastic zip lock |