| Primary Device ID | B631TCGE2GE122F1 |
| NIH Device Record Key | 749029b5-6b89-4e45-87fa-61ab27cf59f2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Surelead |
| Version Model Number | TCGE2GE122F |
| Company DUNS | 078861998 |
| Company Name | Authentic Medical |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| 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 |
|---|---|
| HIBCC | B631TCGE2GE122F1 [Primary] |
| IKD | Cable, Electrode |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-07 |
| Device Publish Date | 2024-10-30 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SURELEAD 98844045 not registered Live/Pending |
Authentic Options LLC 2024-11-08 |