| Primary Device ID | 00850040139938 |
| NIH Device Record Key | 7ba252fb-c9fa-4d2d-9473-f1377fe3ddee |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lateral SI Screw Drill Bit - 8mm |
| Version Model Number | SR21-6005 |
| 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 | 00850040139938 [Primary] |
| OUR | Sacroiliac Joint Fixation |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850040139938]
Moist Heat or Steam Sterilization
[00850040139938]
Moist Heat or Steam Sterilization
[00850040139938]
Moist Heat or Steam Sterilization
[00850040139938]
Moist Heat or Steam Sterilization
[00850040139938]
Moist Heat or Steam Sterilization
[00850040139938]
Moist Heat or Steam Sterilization
[00850040139938]
Moist Heat or Steam Sterilization
[00850040139938]
Moist Heat or Steam Sterilization
[00850040139938]
Moist Heat or Steam Sterilization
[00850040139938]
Moist Heat or Steam Sterilization
[00850040139938]
Moist Heat or Steam Sterilization
[00850040139938]
Moist Heat or Steam Sterilization
[00850040139938]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-11 |
| Device Publish Date | 2024-11-01 |