| Primary Device ID | 20852776006024 |
| NIH Device Record Key | 2e336266-a8ff-4d76-9ca0-f4ae8d9e1950 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DTRAX Bone Screw |
| Version Model Number | PD-32-301 |
| Catalog Number | PD-32-301 |
| Company DUNS | 969820245 |
| Company Name | PROVIDENCE MEDICAL TECHNOLOGY, INC. |
| Device Count | 30 |
| DM Exempt | true |
| 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 | true |
| 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 | 10852776006021 [Unit of Use] |
| GS1 | 20852776006024 [Primary] |
| HWC | Screw, Fixation, Bone |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[20852776006024]
Radiation Sterilization
[20852776006024]
Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-09-15 |
| 10852776006024 | The DTRAX Bone Screw is a single-use implant made of titanium alloy and used in bone reconstruct |
| 20852776006024 | The DTRAX Bone Screw is a single-use implant made of titanium alloy and used in bone reconstruct |
| 20852776006021 | The DTRAX Bone Screw is a single-use implant made of titanium alloy and used in bone reconstruct |