| Primary Device ID | 05060481690041 |
| NIH Device Record Key | 41a3ea93-db4d-4032-b9e0-83e322190fd2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | E-LINK Hand Kit |
| Version Model Number | H500 |
| Company DUNS | 519969810 |
| Company Name | BIOMETRICS LIMITED |
| 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 | false |
| Serial Number | true |
| 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 | 05060481690041 [Primary] |
| ISD | Exerciser, Measuring |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-06-26 |
| Device Publish Date | 2018-02-14 |
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| 05060481690119 - E-LINK Myo-EX GX4 EMG Sensor | 2018-09-10 Highly sensitive Myo-EX sensors use surface EMG for inspiring exercise, beginning from when there is the tiniest flicker of volu |
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