| Primary Device ID | 08809539690735 |
| NIH Device Record Key | ae567b77-4453-4304-80cf-6f84d1669a6f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Surgical Instrument |
| Version Model Number | D8P.31210 |
| Company DUNS | 688999370 |
| Company Name | OSTEONIC CO.,Ltd. |
| 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 | false |
| 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 | 08809539690735 [Primary] |
| HTW | Bit, Drill |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08809539690735]
Moist Heat or Steam Sterilization
[08809539690735]
Moist Heat or Steam Sterilization
[08809539690735]
Moist Heat or Steam Sterilization
[08809539690735]
Moist Heat or Steam Sterilization
[08809539690735]
Moist Heat or Steam Sterilization
[08809539690735]
Moist Heat or Steam Sterilization
[08809539690735]
Moist Heat or Steam Sterilization
[08809539690735]
Moist Heat or Steam Sterilization
[08809539690735]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-03 |
| Device Publish Date | 2025-06-25 |