| Primary Device ID | 00810044843170 |
| NIH Device Record Key | 8092987b-ad76-4cb5-b4ef-0c1e2a807a94 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HexaPLUS S OneDrill Implant System |
| Version Model Number | OFCB525 |
| Company DUNS | 080694564 |
| Company Name | OSSEOFUSE INTERNATIONAL, INC. |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 | 00810044843170 [Primary] |
| DZI | Drill, Bone, Powered |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810044843170]
Moist Heat or Steam Sterilization
[00810044843170]
Moist Heat or Steam Sterilization
[00810044843170]
Moist Heat or Steam Sterilization
[00810044843170]
Moist Heat or Steam Sterilization
[00810044843170]
Moist Heat or Steam Sterilization
[00810044843170]
Moist Heat or Steam Sterilization
[00810044843170]
Moist Heat or Steam Sterilization
[00810044843170]
Moist Heat or Steam Sterilization
[00810044843170]
Moist Heat or Steam Sterilization
[00810044843170]
Moist Heat or Steam Sterilization
[00810044843170]
Moist Heat or Steam Sterilization
[00810044843170]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-03 |
| Device Publish Date | 2025-11-25 |