| Primary Device ID | 00854629006123 |
| NIH Device Record Key | b2d1d776-baed-4996-9ab4-5de1a6845c61 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TightFix Interference Screw 10mm PEEK |
| Version Model Number | DFX0003T |
| Catalog Number | DFX0003T |
| Company DUNS | 079471560 |
| Company Name | DUNAMIS MEDICAL, LLC |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 |
| Phone | 877.454.2186 |
| info@dunamismedical.com | |
| Phone | 877.454.2186 |
| info@dunamismedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00854629006123 [Primary] |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-04-11 |
| 00850052601249 - Orca™ Implantation Kit | 2024-06-28 Orca™ Implantation Kit |
| 00850052601072 - Hallux Guide | 2024-06-18 Hallux Guide |
| 00850052601089 - CMC Spacer | 2024-06-18 CMC Spacer |
| 00850052601096 - CMC Guide | 2024-06-18 CMC Guide |
| 00850052601157 - Threaded Driver | 2024-06-18 Threaded Driver |
| 00850052601232 - Micro Constrictor® Implantation Kit | 2024-06-18 Micro Constrictor® Implantation Kit |
| 00850052601225 - Orca Xtreme ™ Kit Knotless Button | 2024-03-22 Orca Xtreme™ Kit Knotless Button |
| 00850052601188 - Force DFX Suture-Xtreme™ | 2024-02-08 Force DFX Suture-Xtreme™ |