| Primary Device ID | 00846338000776 |
| NIH Device Record Key | 974809ce-f3bf-4274-b07c-f6045d1f0974 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spine Needle (18 Gauge) |
| Version Model Number | DFX-N8/1 |
| 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 | 00846338000776 [Primary] |
| GS1 | 00846338001469 [Package] Package: Box (DFX-N8) [10 Units] In Commercial Distribution |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2019-07-22 |
| Device Publish Date | 2016-09-22 |
| 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 |