| Primary Device ID | 00860004002116 |
| NIH Device Record Key | c6e429d0-0a03-4125-ac47-19cd8746cf93 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FlexDex Needle Driver |
| Version Model Number | FD-335 ND |
| Company DUNS | 967741179 |
| Company Name | FlexDex Surgical |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860004002109 [Primary] |
| GS1 | 00860004002116 [Package] Contains: 00860004002109 Package: [3 Units] In Commercial Distribution |
| MDM | Instrument, Manual, Surgical, General Use |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-29 |
| Device Publish Date | 2022-08-19 |
| 00860004002130 - AXIUS 8mm Needle Driver - Medium | 2023-06-26 |
| 00860004002147 - AXIUS 8mm Needle Driver - Long | 2023-06-26 |
| 00860004002116 - FlexDex Needle Driver | 2022-08-29 |
| 00860004002116 - FlexDex Needle Driver | 2022-08-29 |