| Primary Device ID | 08800041038336 |
| NIH Device Record Key | e2f0bdb5-6d87-4802-afbb-10a44f354360 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Osteotome |
| Version Model Number | S-2.5 |
| Company DUNS | 689846448 |
| Company Name | Surgident 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800041038336 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800041038336]
Moist Heat or Steam Sterilization
[08800041038336]
Moist Heat or Steam Sterilization
[08800041038336]
Moist Heat or Steam Sterilization
[08800041038336]
Moist Heat or Steam Sterilization
[08800041038336]
Moist Heat or Steam Sterilization
[08800041038336]
Moist Heat or Steam Sterilization
[08800041038336]
Moist Heat or Steam Sterilization
[08800041038336]
Moist Heat or Steam Sterilization
[08800041038336]
Moist Heat or Steam Sterilization
[08800041038336]
Moist Heat or Steam Sterilization
[08800041038336]
Moist Heat or Steam Sterilization
[08800041038336]
Moist Heat or Steam Sterilization
[08800041038336]
Moist Heat or Steam Sterilization
[08800041038336]
Moist Heat or Steam Sterilization
[08800041038336]
Moist Heat or Steam Sterilization
[08800041038336]
Moist Heat or Steam Sterilization
[08800041038336]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-13 |
| Device Publish Date | 2023-03-03 |
| 08800041053223 | OST-8 |
| 08800041038411 | R-4.0 |
| 08800041038404 | R-3.5 |
| 08800041038398 | R-3.0 |
| 08800041038381 | R-2.5 |
| 08800041038374 | R-2.0 |
| 08800041038367 | S-4.0 |
| 08800041038350 | S-3.5 |
| 08800041038343 | S-3.0 |
| 08800041038336 | S-2.5 |
| 08800041038329 | S-2.0 |