| Primary Device ID | B14086201200 |
| NIH Device Record Key | 8820fdb7-dd09-4076-9af3-2d4409d80e91 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BRAEBON Leadwire Kit |
| Version Model Number | 8620-120 |
| Catalog Number | 8620-120 |
| Company DUNS | 251731105 |
| Company Name | Braebon Medical Corporation |
| Device Count | 10 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Phone | 613.831.6690 |
| info@braebon.com | |
| Phone | 613.831.6690 |
| info@braebon.com | |
| Phone | 613.831.6690 |
| info@braebon.com | |
| Phone | 613.831.6690 |
| info@braebon.com | |
| Phone | 613.831.6690 |
| info@braebon.com | |
| Phone | 613.831.6690 |
| info@braebon.com | |
| Phone | 613.831.6690 |
| info@braebon.com | |
| Phone | 613.831.6690 |
| info@braebon.com | |
| Phone | 613.831.6690 |
| info@braebon.com | |
| Phone | 613.831.6690 |
| info@braebon.com | |
| Phone | 613.831.6690 |
| info@braebon.com | |
| Phone | 613.831.6690 |
| info@braebon.com | |
| Phone | 613.831.6690 |
| info@braebon.com | |
| Phone | 613.831.6690 |
| info@braebon.com | |
| Phone | 613.831.6690 |
| info@braebon.com | |
| Phone | 613.831.6690 |
| info@braebon.com | |
| Phone | 613.831.6690 |
| info@braebon.com |
| Length | 120 Inch |
| Length | 120 Inch |
| Length | 120 Inch |
| Length | 120 Inch |
| Length | 120 Inch |
| Length | 120 Inch |
| Length | 120 Inch |
| Length | 120 Inch |
| Length | 120 Inch |
| Length | 120 Inch |
| Length | 120 Inch |
| Length | 120 Inch |
| Length | 120 Inch |
| Length | 120 Inch |
| Length | 120 Inch |
| Length | 120 Inch |
| Length | 120 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B14086201200 [Unit of Use] |
| HIBCC | B14086201201 [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 | 2024-09-23 |
| Device Publish Date | 2024-09-13 |
| B1408620720 | Leads for connecting electrodes to a PSG. |
| B1408620600 | Leads for connecting electrodes to a PSG. |
| B14086201200 | Leads for connecting electrodes to a PSG. |