| Primary Device ID | 00846338001384 |
| NIH Device Record Key | 0cdf3ec3-674b-4d6d-a65d-5523fbf48e4b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Disc-FX® Mini System |
| Version Model Number | DFXM |
| Company DUNS | 019872358 |
| Company Name | ELLIQUENCE, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 | 00846338001384 [Primary] |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-04-23 |
| Device Publish Date | 2017-02-03 |
| 00846338002688 - Motor | 2025-01-20 |
| 00846338005566 - Retractor | 2025-01-20 |
| 00846338005573 - Retractor | 2025-01-20 |
| 00846338005634 - Bone Curette | 2025-01-20 |
| 00846338005641 - Bone Curette | 2025-01-20 |
| 00846338005658 - Bone Curette | 2025-01-20 |
| 00846338005665 - Bone Curette | 2025-01-20 |
| 00846338005672 - Bone Curette | 2025-01-20 |