| Primary Device ID | D785GUIDEDSURGERYKIT0 |
| NIH Device Record Key | ac15a045-21da-411d-8c07-01961a0c9422 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SURGICAL KIT |
| Version Model Number | GUIDED SURGERY SURGICAL INSTRUMENTATION KIT |
| Catalog Number | GUIDED SURGERY KIT |
| 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 | true |
| 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 | D785GUIDEDSURGERYKIT0 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D785GUIDEDSURGERYKIT0]
Moist Heat or Steam Sterilization
[D785GUIDEDSURGERYKIT0]
Moist Heat or Steam Sterilization
[D785GUIDEDSURGERYKIT0]
Moist Heat or Steam Sterilization
[D785GUIDEDSURGERYKIT0]
Moist Heat or Steam Sterilization
[D785GUIDEDSURGERYKIT0]
Moist Heat or Steam Sterilization
[D785GUIDEDSURGERYKIT0]
Moist Heat or Steam Sterilization
[D785GUIDEDSURGERYKIT0]
Moist Heat or Steam Sterilization
[D785GUIDEDSURGERYKIT0]
Moist Heat or Steam Sterilization
[D785GUIDEDSURGERYKIT0]
Moist Heat or Steam Sterilization
[D785GUIDEDSURGERYKIT0]
Moist Heat or Steam Sterilization
[D785GUIDEDSURGERYKIT0]
Moist Heat or Steam Sterilization
[D785GUIDEDSURGERYKIT0]
Moist Heat or Steam Sterilization
[D785GUIDEDSURGERYKIT0]
Moist Heat or Steam Sterilization
[D785GUIDEDSURGERYKIT0]
Moist Heat or Steam Sterilization
[D785GUIDEDSURGERYKIT0]
Moist Heat or Steam Sterilization
[D785GUIDEDSURGERYKIT0]
Moist Heat or Steam Sterilization
[D785GUIDEDSURGERYKIT0]
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 |
| D785GUIDEDSURGERYKIT0 | GUIDED SURGERY SURGICAL INSTRUMENTATION KIT |
| D785ENGAGECOMPACTKIT0 | ENGAGE SURGICAL INSTRUMENTATION COMPACT KIT |