| Primary Device ID | 00858406007709 |
| NIH Device Record Key | e7da43da-df3d-4975-a034-5806ae9f6ead |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GraftRasp Teeth and Set Screw - Bladed |
| Version Model Number | 3D-D05-07 |
| Company DUNS | 004095409 |
| Company Name | SURGENTEC, LLC |
| Device Count | 1 |
| DM Exempt | false |
| 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 | 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 | 00858406007709 [Primary] |
| HTR | Rasp |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00858406007709]
Moist Heat or Steam Sterilization
[00858406007709]
Moist Heat or Steam Sterilization
[00858406007709]
Moist Heat or Steam Sterilization
[00858406007709]
Moist Heat or Steam Sterilization
[00858406007709]
Moist Heat or Steam Sterilization
[00858406007709]
Moist Heat or Steam Sterilization
[00858406007709]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2022-06-10 |
| Device Publish Date | 2020-11-19 |