| Primary Device ID | B681J000970 |
| NIH Device Record Key | dce00d62-728a-4172-a2a9-2dcea6df2dde |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IMACTIS® |
| Version Model Number | J00097 |
| Catalog Number | MA-J00097 |
| Company DUNS | 260527568 |
| Company Name | IMACTIS |
| 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 | false |
| Serial Number | true |
| 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 | B681J000970 [Primary] |
| HIBCC | B681J000971 [Package] Package: cardboard [1 Units] In Commercial Distribution |
| BZN | Cart, Emergency, Cardiopulmonary (Excluding Equipment) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-01-08 |
| Device Publish Date | 2018-12-08 |
| B681J020000 | Navigation station of the IMACTIS® CT-NAVIGATION system |
| B681J001971 | Transport suitcase for the navigation station of the IMACTIS® CT-NAVIGATION system |
| B681J00099US0 | Power cable of the IMACTIS® CT-NAVIGATION system |
| B681J000970 | Cart for the IMACTIS® CT-NAVIGATION system |
| B681I101002 | Single use Navigation Kit of the IMACTIS® CT-NAVIGATION system |
| B681A102001 | Non-sterile needle holder of the IMACTIS® CT-NAVIGATION system |
| B681A100101 | Sterile needle holder of the IMACTIS® CT-NAVIGATION system |