| Primary Device ID | 00860002094700 |
| NIH Device Record Key | 90718478-d8fd-4996-9b90-d0de2b6a238e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SX-One MicroKnife |
| Version Model Number | 600112-001 |
| Catalog Number | 600112-001 |
| Company DUNS | 040211080 |
| Company Name | SONEX HEALTH, INC. |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860002094700 [Primary] |
| GS1 | 00860002094717 [Package] Package: Box [3 Units] In Commercial Distribution |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-22 |
| Device Publish Date | 2020-09-14 |