| Primary Device ID | 04931921005477 |
| NIH Device Record Key | 7158be3d-298f-4914-84be-529b5d7e79a1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Neuropack S3 |
| Version Model Number | JB-910B |
| Company DUNS | 690568050 |
| Company Name | NIHON KOHDEN CORPORATION |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04931921005477 [Primary] |
| IKN | Electromyograph, diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-09-17 |
| Device Publish Date | 2018-08-16 |
| 04931921007327 | ATTACHMENT for RY-960B |
| 04931921006429 | UPGRADE SOFTWARE PROGRAM |
| 04931921005552 | POWER SUPPLY UNIT for LAPTOP PC (100-120V) |
| 04931921005545 | SOMATO CONTROL BOX |
| 04931921005491 | 4ch ELECTRODE JUNCTION BOX |
| 04931921005484 | 2ch ELECTRODE JUNCTION BOX |
| 04931921005477 | BREAKOUT BOX for ELECTRODE JUNCTION BOX |
| 04931921005439 | Main unit for MEB-9600 Neuropack S3 desktop system, performs Evoked potentials, nerve conduction |