| Primary Device ID | 00860007130410 |
| NIH Device Record Key | 28da81a5-a83d-4e61-99a9-4122446e4cfe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DuraFuse Dural Clip Applier |
| Version Model Number | AP-100 |
| Company DUNS | 079885939 |
| Company Name | Neuramedica Inc. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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 | 503-914-0723 |
| rachel@NeuraMedica.com | |
| Phone | 503-914-0723 |
| rachel@NeuraMedica.com | |
| Phone | 503-914-0723 |
| rachel@NeuraMedica.com | |
| Phone | 503-914-0723 |
| rachel@NeuraMedica.com | |
| Phone | 503-914-0723 |
| rachel@NeuraMedica.com | |
| Phone | 503-914-0723 |
| rachel@NeuraMedica.com | |
| Phone | 503-914-0723 |
| rachel@NeuraMedica.com | |
| Phone | 503-914-0723 |
| rachel@NeuraMedica.com | |
| Phone | 503-914-0723 |
| rachel@NeuraMedica.com | |
| Phone | 503-914-0723 |
| rachel@NeuraMedica.com | |
| Phone | 503-914-0723 |
| rachel@NeuraMedica.com | |
| Phone | 503-914-0723 |
| rachel@NeuraMedica.com | |
| Phone | 503-914-0723 |
| rachel@NeuraMedica.com | |
| Phone | 503-914-0723 |
| rachel@NeuraMedica.com | |
| Phone | 503-914-0723 |
| rachel@NeuraMedica.com | |
| Phone | 503-914-0723 |
| rachel@NeuraMedica.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860007130410 [Primary] |
| FZP | Clip, Implantable |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-05-23 |
| Device Publish Date | 2023-05-15 |
| 00860007130410 - DuraFuse Dural Clip Applier | 2023-05-23The NeuraMedica Applier is a separately-supplied reusable instrument that aids in the installation of the NeuraMedica Durafuse Dural Clips. |
| 00860007130410 - DuraFuse Dural Clip Applier | 2023-05-23 The NeuraMedica Applier is a separately-supplied reusable instrument that aids in the installation of the NeuraMedica Durafuse D |
| 00860007130427 - DuraFuse Dural Clip Instrument Tray | 2023-05-23 The NeuraMedica Instrument Tray is a separately-supplied reusable surgical tray that holds the instrument that aids in the insta |
| 00860007130434 - DuraFuse Dural Clip Instrument Tray W/ Appliers | 2023-05-23 The NeuraMedica Instrument Tray is a separately-supplied reusable surgical tray that holds the instrument that aids in the insta |
| 00860007130403 - DuraFuse Dural Clip | 2023-03-17 NeuraMedica Dural Clips are bioabsorbable surgical clips designed to aid in closure of the dura mater in neurosurgical and ortho |