| Primary Device ID | 00850384007092 |
| NIH Device Record Key | 6cd76819-dd50-4652-bd87-d3a8463b3a08 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EMG Cable for Nerveäna |
| Version Model Number | CEMGB |
| Company DUNS | 088091038 |
| Company Name | AFFINITY MEDICAL TECHNOLOGIES, 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 | 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850384007092 [Primary] |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) |
| 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 | 2016-09-23 |
| 00850384007009 - Affinity Cable and Leadwire System | 2018-03-29 |
| 00850384007016 - Affinity Cable and Leadwire System | 2018-03-29 |
| 00850384007023 - Affinity Cable and Leadwire System | 2018-03-29 |
| 00850384007030 - Affinity Cable and Leadwire System | 2018-03-29 |
| 00850384007047 - Affinity Cable and Leadwire System | 2018-03-29 |
| 00850384007054 - Affinity Cable and Leadwire System | 2018-03-29 |
| 00850384007085 - Affinity Cable and Leadwire System | 2018-03-29 |
| 00850384007092 - EMG Cable for Nerveäna | 2018-03-29 |
| 00850384007092 - EMG Cable for Nerveäna | 2018-03-29 |