| Primary Device ID | D785GS325R90 |
| NIH Device Record Key | e011c2c5-aad8-4f4b-bb08-3b74b322872c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Guided Surgery Ratchet |
| Version Model Number | 3.25 Guided Surgery Ratchet |
| Catalog Number | GS3.25 R9 |
| 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 | D785GS325R90 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D785GS325R90]
Moist Heat or Steam Sterilization
[D785GS325R90]
Moist Heat or Steam Sterilization
[D785GS325R90]
Moist Heat or Steam Sterilization
[D785GS325R90]
Moist Heat or Steam Sterilization
[D785GS325R90]
Moist Heat or Steam Sterilization
[D785GS325R90]
Moist Heat or Steam Sterilization
[D785GS325R90]
Moist Heat or Steam Sterilization
[D785GS325R90]
Moist Heat or Steam Sterilization
[D785GS325R90]
Moist Heat or Steam Sterilization
[D785GS325R90]
Moist Heat or Steam Sterilization
[D785GS325R90]
Moist Heat or Steam Sterilization
[D785GS325R90]
Moist Heat or Steam Sterilization
[D785GS325R90]
Moist Heat or Steam Sterilization
[D785GS325R90]
Moist Heat or Steam Sterilization
[D785GS325R90]
Moist Heat or Steam Sterilization
[D785GS325R90]
Moist Heat or Steam Sterilization
[D785GS325R90]
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 |
| D785GS50R90 | 5.0 Guided Surgery Ratchet 9mm Length |
| D785GS50R80 | 5.0 Guided Surgery Ratchet 8mm Length |
| D785GS50R100 | 5.0 Guided Surgery Ratchet 10mm Length |
| D785GS40R90 | 4.0 Guided Surgery Ratchet 9mm Length |
| D785GS40R80 | 4.0 Guided Surgery Ratchet 8mm Length |
| D785GS40R100 | 4.0 Guided Surgery Ratchet 10mm Length |
| D785GS325R90 | 3.25 Guided Surgery Ratchet 9mm Length |
| D785GS325R100 | 3.25 Guided Surgery Ratchet 10mm Length |