| Primary Device ID | D7850290GS280 |
| NIH Device Record Key | 4205b332-aa7d-4564-adeb-a4f2fe10c28e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Guided Surgery Final Drill |
| Version Model Number | 2.9mm Guided Surgery Final Drill 28mm |
| Catalog Number | 0290GS28 |
| Company DUNS | 094146123 |
| Company Name | OCO BIOMEDICAL INC |
| 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 |
|---|---|
| HIBCC | D7850290GS280 [Primary] |
| DZA | Drill, Dental, Intraoral |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D7850290GS280]
Moist Heat or Steam Sterilization
[D7850290GS280]
Moist Heat or Steam Sterilization
[D7850290GS280]
Moist Heat or Steam Sterilization
[D7850290GS280]
Moist Heat or Steam Sterilization
[D7850290GS280]
Moist Heat or Steam Sterilization
[D7850290GS280]
Moist Heat or Steam Sterilization
[D7850290GS280]
Moist Heat or Steam Sterilization
[D7850290GS280]
Moist Heat or Steam Sterilization
[D7850290GS280]
Moist Heat or Steam Sterilization
[D7850290GS280]
Moist Heat or Steam Sterilization
[D7850290GS280]
Moist Heat or Steam Sterilization
[D7850290GS280]
Moist Heat or Steam Sterilization
[D7850290GS280]
Moist Heat or Steam Sterilization
[D7850290GS280]
Moist Heat or Steam Sterilization
[D7850290GS280]
Moist Heat or Steam Sterilization
[D7850290GS280]
Moist Heat or Steam Sterilization
[D7850290GS280]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-20 |
| Device Publish Date | 2024-03-12 |
| D7850460GS280 | 4.6mm Guided Surgery Final Drill 28mm Length |
| D7850460GS250 | 4.6mm Guided Surgery Final Drill 25mm Length |
| D7850460GS230 | 4.6mm Guided Surgery Final Drill 23mm Length |
| D7850460GS200 | 4.6mm Guided Surgery Final Drill 20mm Length |
| D7850460GS180 | 4.6mm Guided Surgery Final Drill 18mm Length |
| D7850460GS150 | 4.6mm Guided Surgery Final Drill 15mm Length |
| D7850360GS280 | 3.6mm Guided Surgery Final Drill 28mm Length |
| D7850360GS250 | 3.6mm Guided Surgery Final Drill 25mm Length |
| D7850360GS230 | 3.6mm Guided Surgery Final Drill 23mm Length |
| D7850360GS200 | 3.6mm Guided Surgery Final Drill 20mm Length |
| D7850360GS180 | 3.6mm Guided Surgery Final Drill 18mm Length |
| D7850360GS150 | 3.6mm Guided Surgery Final Drill 15mm Length |
| D7850290GS280 | 2.9mm Guided Surgery Final Drill 28mm Length |
| D7850290GS250 | 2.9mm Guided Surgery Final Drill 25mm Length |
| D7850290GS230 | 2.9mm Guided Surgery Final Drill 23mm Length |
| D7850290GS200 | 2.9mm Guided Surgery Final Drill 20mm Length |
| D7850290GS180 | 2.9MM Guided Surgery Final Drill 18MM Length |
| D7850290GS150 | 2.9mm Guided Surgery Final Drill 15mm Length |