| Primary Device ID | 00851674008553 |
| NIH Device Record Key | c12f0e25-b93c-43be-8bdf-8b2e20cc4fa2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EnVisio System |
| Version Model Number | ENVISIO-SYS |
| Company DUNS | 079322481 |
| Company Name | Elucent Medical, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| 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 |
|---|---|
| GS1 | 00851674008553 [Primary] |
| NEU | Marker, Radiographic, 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 | 2025-02-12 |
| Device Publish Date | 2025-02-04 |
| 00851674008560 - SmartClip Lite - Eval Kit | 2026-03-05 SmartClip Lite- Evaluation Kit |
| 00851674008577 - SmartClip | 2026-02-24 Soft Tissue Marker and Delivery System - Violet, 5 cm (T-Lock) |
| 00851674008584 - SmartClip | 2026-02-24 Soft Tissue Marker and Delivery System - Violet, 7.5 cm (T-Lock) |
| 00851674008591 - SmartClip | 2026-02-24 Soft Tissue Marker and Delivery System - Violet, 10 cm (T-Lock) |
| 00851674008607 - SmartClip Secure | 2026-02-24 Soft Tissue Marker and Delivery System - Violet (T-Lock) |
| 10851674008352 - SmartClip Secure | 2025-06-09 Soft Tissue Marker and Delivery System - Pink |
| 10851674008369 - SmartClip Secure | 2025-06-09 Soft Tissue Marker and Delivery System - Green |
| 10851674008376 - SmartClip Secure | 2025-06-09 Soft Tissue Marker and Delivery System - Purple |