| Primary Device ID | 80092237900846 |
| NIH Device Record Key | d5a821fe-b0e9-48a4-ba8c-2f0a1bceefcd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Karatrode |
| Version Model Number | 203-343 |
| Company DUNS | 080930531 |
| Company Name | Compass Richmar, LLC |
| Device Count | 4 |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 | 00092237900840 [Primary] |
| GS1 | 01092237900849 [Unit of Use] |
| GS1 | 30092237900841 [Package] Contains: 00092237900840 Package: Inner Carton [10 Units] In Commercial Distribution |
| GS1 | 80092237900846 [Package] Contains: 30092237900841 Package: Master carton [50 Units] In Commercial Distribution |
| GXY | Electrode, Cutaneous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-11-19 |
| Device Publish Date | 2018-10-19 |
| 30092237900872 | 3" Round Cloth |
| 80092237900860 | 2"x 3.5" Cloth |
| 80092237900853 | 2"x 2" Cloth |
| 80092237900846 | 2"x 2" Foam |
| 80092237900839 | 2" Round Cloth |
| 00850689007643 | 3" Round Cloth |
| 00850689007636 | 2"x 3.5" Cloth |
| 00850689007629 | 2"x 2" Cloth |
| 00850689007612 | 2"x 2" Foam |
| 00850689007605 | 2" Round Cloth |
| 10850689007640 | 3" Round Cloth, Case of 10 |
| 10850689007633 | 2"x 3.5" Cloth, Case of 10 |
| 10850689007626 | 2"x 2" Cloth, Case of 10 |
| 10850689007619 | 2"x 2" Foam, Case of 10 |
| 10850689007602 | 2" Round Cloth, Case of 10 |