| Primary Device ID | 30853512006647 |
| NIH Device Record Key | 29bedeb2-893e-4502-aac9-c4b37bbe8ae1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NikoSurg |
| Version Model Number | 4800 |
| Catalog Number | 4800 |
| Company DUNS | 073648341 |
| Company Name | NIKOMED USA |
| 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 | 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 |
| Phone | +1(800)355-6456 |
| info@nikomedusa.com |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10853512006643 [Primary] |
| GS1 | 20853512006640 [Package] Contains: 10853512006643 Package: Bx [25 Units] In Commercial Distribution |
| GS1 | 30853512006647 [Package] Contains: 20853512006640 Package: Cs [4 Units] In Commercial Distribution |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-06-03 |
| Device Publish Date | 2019-05-24 |
| 30853512006647 | Neutral Electrodes |
| 10853512006636 | Neutral Electrodes |
| 20853512006640 | Neutral Electrodes |