| Primary Device ID | 10859911006024 |
| NIH Device Record Key | 188f5f2c-28fc-4d40-a6e1-3e1aa56e723d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Biowave Percutaneous Electrodes |
| Version Model Number | MK78515 - BWEP02-E |
| Company DUNS | 005759084 |
| Company Name | BIOWAVE 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| Phone | 1-877-246-9283 |
| info@biowave.com |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00859911006027 [Primary] |
| GS1 | 10859911006024 [Package] Contains: 00859911006027 Package: 6-pack zip lock - E [6 Units] In Commercial Distribution |
| GS1 | 20859911006021 [Package] Package: Case - Perc E [72 Units] In Commercial Distribution |
| NHI | Stimulator, Nerve, Electrial, Percutaneous (Pens), For Pain Relief |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-12-23 |
| Device Publish Date | 2016-08-01 |
| 10859911006024 | Biowave Percutaneous Electrode Set - E |
| 20859911006007 | Biowave Percutaneous Electrode Set - B |