| Primary Device ID | 00092237901731 |
| NIH Device Record Key | e590e8e9-976f-4058-8942-5044343c7a75 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Therasound EVO 3.5P |
| Version Model Number | 400-020 |
| Company DUNS | 080930531 |
| Company Name | Compass Richmar, LLC |
| 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 |
| Phone | 1-888-549-4945 |
| customerservice@richmarweb.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00092237901731 [Primary] |
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-11-12 |
| Device Publish Date | 2018-10-10 |
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