| Primary Device ID | 08800071020950 |
| NIH Device Record Key | 226e6003-902b-4692-8e1b-23895f14ed36 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Genie Labral Instruments |
| Version Model Number | BIS-2610-DR |
| 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 | 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 | 08800071020950 [Primary] |
| HTW | Bit, Drill |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800071020950]
Moist Heat or Steam Sterilization
[08800071020950]
Moist Heat or Steam Sterilization
[08800071020950]
Moist Heat or Steam Sterilization
[08800071020950]
Moist Heat or Steam Sterilization
[08800071020950]
Moist Heat or Steam Sterilization
[08800071020950]
Moist Heat or Steam Sterilization
[08800071020950]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-29 |
| Device Publish Date | 2021-07-21 |
| 08800071020950 | BIS-2610-DR |
| 08800071020943 | BIS-2110-DR |
| 08800071020936 | BIS-04225-DG |