| Primary Device ID | 00814247020529 |
| NIH Device Record Key | 6b22cdbe-6150-4cca-abdd-db46e943bf59 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FSE Cables |
| Version Model Number | SBT-7011 |
| Company DUNS | 809524291 |
| Company Name | CLINICAL INNOVATIONS, 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 | 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 | 00814247020529 [Primary] |
| HGP | Electrode, Circular (Spiral), Scalp And Applicator |
| 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 | 2016-09-01 |
| 00814247020598 | Cables to FSE |
| 00814247020581 | Cables to FSE |
| 00814247020574 | Cables to FSE |
| 00814247020567 | Cables to FSE |
| 00814247020550 | Cables to FSE |
| 00814247020543 | Cables to FSE |
| 00814247020536 | Cables to FSE |
| 00814247020529 | Cables to FSE |
| 00814247020512 | Cables to FSE |
| 00814247021205 | DECG Reusable Legplate Adapter Cable |